J.R. Simplot Company Petition (13-022-01p) for 

Determination of Non-Regulated Status for InnateTM 

Potatoes with Low Acrylamide Potential and Reduced 

Black Spot Bruise: Events E12 and E24 (Russet Burbank); 

F10 and F37 (Ranger Russet); J3, J55, and J78 (Atlantic); 

G11 (G); H37 and H50 (H)

OECD Unique Identifiers: SPS-00F10-7; SPS-00F37-7; 

SPS-0E12-8; SPS-00E24-2; SPS-000J3-4; SPS-00J55-2;

SPS-00J78-7; SPS-00G11-9; SPS-00H37-9; SPS-00H50-4

Final Environmental Assessment 

July 2014

Agency Contact 

Cindy Eck

Biotechnology Regulatory Services

4700 River Road 

USDA, APHIS 

Riverdale, MD 20737 

Fax: (301) 734-8669

i
The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of 

race, color, national origin, sex, religion, age, disability, political beliefs, sexual orientation, or marital or family status. 

(Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for 

communication of program information (Braille, large print, audiotape, etc.) should contact USDA’S TARGET Center at 

(202) 720–2600 (voice and TDD). 

To file a complaint of discrimination, write USDA, Director, Office of Civil Rights, Room 326–W, Whitten Building, 1400 

Independence Avenue, SW, Washington, DC 20250–9410 or call (202) 720–5964 (voice and TDD). USDA is an equal 

opportunity provider and employer. 

Mention of companies or commercial products in this report does not imply recommendation or endorsement by the 

U.S. Department of Agriculture over others not mentioned. USDA neither guarantees nor warrants the standard of any 

product mentioned. Product names are mentioned solely to report factually on available data and to provide specific 

information. 

This publication reports research involving pesticides. All uses of pesticides must be registered by appropriate State 

and/or Federal agencies before they can be recommended. 

ii
TABLE OF CONTENTS PAGE

LIST OF FIGURES........................................................................................................................ vii

LIST OF TABLES.......................................................................................................................... vii

ACRONYMS AND ABBREVIATIONS ........................................................................................... viii

1 PURPOSE AND NEED ............................................................................................................... 1

1.1 Background ........................................................................................................................... 1

1.1.1 The APHIS Regulatory Authority .............................................................................. 1

1.1.2 Purpose of this Product............................................................................................ 2

1.2 Coordinated Regulatory Framework for Genetically-Engineered Organisms ......................3

1.2.1 USDA-APHIS.................................................................................................................... 3

1.2.2 Environmental Protection Agency.................................................................................. 4

1.2.3 Food and Drug Administration....................................................................................... 5

1.3 Purpose and Need for This APHIS Action.............................................................................. 5

1.3.1 Public Involvement......................................................................................................... 6

1.3.2 Public Involvement Approach for This EA ...................................................................... 7

1.4 Issues Considered.................................................................................................................. 9

2 AFFECTED ENVIRONMENT .................................................................................................... 11

2.1 Agricultural Production and Agronomic Practices of Potato..............................................11

2.1.1 Land Use ....................................................................................................................... 11

2.1.2 General Agronomic Practices....................................................................................... 15

2.2 Physical Environment.......................................................................................................... 24

2.2.1 Water Resources.......................................................................................................... 24

2.2.2 Soil Quality.................................................................................................................... 26

2.2.3 Air Quality..................................................................................................................... 27

iii
TABLE OF CONTENTS (Continued) PAGE

2.2.4 Climate Change ............................................................................................................ 28

2.3 Biological Resources............................................................................................................ 29

2.3.1 Animal Communities.................................................................................................... 29

2.3.2 Plant Communities....................................................................................................... 30

2.3.3 Gene Flow and Weediness........................................................................................... 30

2.3.4 Microorganisms............................................................................................................ 32

2.3.5 Biodiversity................................................................................................................... 33

2.4 Human and Animal Health.................................................................................................. 34

2.4.1 Consumer Health.......................................................................................................... 34

2.4.2 Worker Health.............................................................................................................. 37

2.4.3 Animal Feed.................................................................................................................. 37

2.5 Socioeconomics................................................................................................................... 39

2.5.1 Domestic Economic Environment ................................................................................ 40

2.5.2 Trade Economic Environment...................................................................................... 43

2.5.3 Organically Certified Economic Environment ..............................................................44

3. ALTERNATIVES............................................................................................................................ 46

3.1 No Action Alternative: Continuation as a Regulated Article..............................................46

3.2 Preferred Alternative: Determination That Simplot InnateTM Potato Is No Longer a Regulated 

Article ............................................................................................................................ 46

3.3 Alternatives Considered But Rejected from Further Consideration...................................46

3.3.1 Prohibit Any Simplot InnateTM Potato from Being Released ........................................47

3.3.2 Approve the Petition in Part......................................................................................... 47

3.3.3 Isolation Distance between Simplot InnateTM Potato and Non-GE Potato Production 

and Geographical Restrictions...............................................................................47

3.3.4 Requirement of Testing for Simplot InnateTM Potato ...................................................48

3.4 Comparison of Alternatives ................................................................................................ 48

iv
TABLE OF CONTENTS (Continued) PAGE

4 ENVIRONMENTAL CONSEQUENCES............................................................................................ 54

4.1 Environmental Consequences............................................................................................. 54

4.2 Scope of Analysis................................................................................................................. 54

4.3 Agricultural Production of Potato....................................................................................... 55

4.3.1 Acreage and Area of Potato Production ......................................................................55

4.3.2 Agronomic Practices..................................................................................................... 56

4.3.3 Potato Seed Production ............................................................................................... 57

4.3.4 Organic Potato Production........................................................................................... 57

4.4 Physical Environment.......................................................................................................... 58

4.4.1 Water Resources.......................................................................................................... 58

4.4.2 Soil Quality.................................................................................................................... 59

4.4.3 Air Quality..................................................................................................................... 59

4.4.4 Climate Change ............................................................................................................ 60

4.5. Biological Resources........................................................................................................... 60

4.5.1 Animal Communities.................................................................................................... 60

4.5.2 Plant Communities....................................................................................................... 64

4.5.3 Gene Flow and Weediness........................................................................................... 64

4.5.4 Microorganisms............................................................................................................ 65

4.4.5 Biodiversity................................................................................................................... 65

4.6 Human and Animal Health.................................................................................................. 66

4.6.1 Human Health .............................................................................................................. 66

4.6.2 Worker Safety............................................................................................................... 67

4.6.3 Animal Feed.................................................................................................................. 68

4.7 Socioeconomic Impacts ...................................................................................................... 69

4.7.1 Domestic Economic Environment ................................................................................ 69

v
TABLE OF CONTENTS (Continued) PAGE

4.7.2 Trade Economic Environment...................................................................................... 70

5 CUMULATIVE IMPACTS ......................................................................................................... 72

5.1 Assumptions Used for Cumulative Impacts Analysis..........................................................72

5.2 Past and Present and Reasonably Foreseeable Actions .....................................................73

6 THREATENED AND ENDANGERED SPECIES ...........................................................................77

6.1 Potential Effects of Simplot InnateTM Potato on TES and Critical Habitat .....................80

7 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES RELATING TO

ENVIRONMENTAL IMPACTS ................................................................................................. 85

7.1 Executive Orders with Domestic Implications ....................................................................85

7.2 International Implications................................................................................................... 88

7.3 Compliance with Clean Water Act and Clean Air Act..........................................................89

7.4 Impacts on Unique Characteristics of Geographic Areas....................................................89

7.5 Impacts on Unique Characteristics of Geographic Areas....................................................90

7.6 National Historic Preservation Act (NHPA) of 1966 as Amended.......................................90

8 REFERENCES .......................................................................................................................... 92

vi
LIST OF FIGURES

Figure 1. Potato Growing Regions of the United States (USDA-NASS, 2007)............................................12

LIST OF TABLES

Table 1. Major Potato Production States.................................................................................................... 13

Table 2. U.S. 2012 Potato Harvest by State .............................................................................................. 14

Table 3. Major Insect Pests of Potato ........................................................................................................ 18

Table 4. Major Diseases of Potato ............................................................................................................. 19

Table 5. Major Weeds of Potato ................................................................................................................ 21

Table 6. U.S. Per Capita Potato Consumption 2011................................................................................... 34

Table 7. U.S. 2012 Potato Utilization ......................................................................................................... 38

Table 8. A Sample of U.S. Potato Varieties and their Uses........................................................................ 40

Table 9. Summary of Issues of Potential Impacts and Consequences of Alternatives..............................48

vii
 ACRONYMS AND ABBREVIATIONS

AMS Agricultural Marketing Service (within USDA)

AOSCA American Organization of Seed Certifying Agencies

APHIS Animal and Plant Health Inspection Service (within USDA AMS)

BRS Biotechnology Regulatory Services (within USDA–APHIS)

CAA Clean Air Act

CBD Convention on Biological Diversity

CEQ Council on Environmental Quality

CFR Code of Federal Regulations (United States)

CH4 Methane

CO carbon monoxide

CO2 carbon dioxide

CWA

DNA 

Clean Water Act

deoxyribonucleic acid

EA environmental assessment

EIS environmental impact statement

EO Executive Order

EPA U.S. Environmental Protection Agency

ESA Endangered Species Act of 1973

FDA U.S. Food and Drug Administration 

FFDCA Federal Food, Drug, and Cosmetic Act

FFP food, feed, or processing

FIFRA

FONSI

FQPA

Federal Insecticide, Fungicide, and Rodenticide Act

Finding of No Significant Impact

Food Quality Protection Act

viii
 ACRONYMS AND ABBREVIATIONS

FR

FWS

Federal Register

Fish and Wildlife Service (of the U.S)

GE genetically engineered

GHG greenhouse gas

IPM

IPPC

Integrated Pest Management

International Plant Protection Convention

ISPM International Standard for Phytosanitary Measures

LMO

M

NGO

living modified organism

Million

non-government organization

NO2 nitrogen dioxide

N2O nitrous oxide

NAAQS National Ambient Air Quality Standards

NABI North American Biotechnology Initiative

NAPPO North American Plant Protection Organization

NEPA National Environmental Policy Act (of 1969 and subsequent amendments)

NHPA

NMFS

NOP

NPS

NRC

NRCS

PIP

PM

PPA

National Historic Preservation Act

National Marine Fisheries Service

National Organic Program (of USDA AMS)

non-point source

National Research Council

Natural Resources Conservation Service

Plant-incorporated protectants

Particulate matter

Plant Protection Act

ix
 ACRONYMS AND ABBREVIATIONS

PPM

PPRA

RNA

SSA

TES

TPS

U.S.

USDA

USDA-ERS

USDA-FAS

USDA-NASS

USDA-NOP

WPS

parts per million

Plant Pest Risk Assessment

ribonucleic acid

sole source aquifer

threatened and endangered species

true potato seed

United States

U.S. Department of Agriculture

U.S. Department of Agriculture-Economic Research Service

U.S. Department of Agriculture-Foreign Agricultural Service

U.S. Department of Agriculture-National Agricultural Statistics Service

U.S. Department of Agriculture-National Organic Program

Worker Protection Standard (for agricultural pesticides)

x
1 PURPOSE AND NEED

1.1 Background

J.R. Simplot1 of Boise, Idaho, submitted petition 13-022-01p to the United States Department of 

Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) in March 2013, seeking a 

determination of nonregulated status for Simplot InnateTM potato genetically engineered (GE) with low 

acrylamide potential and reduced black spot bruise (events E12 and E24 (Russet Burbank); F10 and F37 

(Ranger Russet); J3, J55, and J78 (Atlantic); G11 (G); and H37 and H50 (H)). The petition was deemed 

complete by APHIS on March 22, 2013. Simplot InnateTM potato is currently regulated under 7 CFR part 

340. Interstate movements and field trials of Simplot InnateTM potato have been conducted under 

permits issued or notifications acknowledged by APHIS since 2009. These field trials were conducted in 

Florida, Indiana, Idaho, Michigan, Nebraska, North Dakota, Washington, and Wisconsin. Data resulting 

from these field trials are similar to data requirements for other petitions submitted to APHIS and 

described in Simplot’s InnateTM potato petition (Simplot, 2013b) and analyzed for plant pest risk in the 

APHIS Plant Pest Risk Assessment (PPRA) (USDA-APHIS, 2013a). Data from field trials is analyzed and 

evaluated in ways that assess treatment differences and statistically account for biological variation.

The petition stated that APHIS should not regulate Simplot InnateTM potato because it does not present a 

plant pest risk. In the event of a determination of nonregulated status, the nonregulated status would 

include Simplot InnateTM potato, any progeny derived from crosses between Simplot InnateTM potato and 

conventional potato, and crosses of Simplot InnateTM potato with other biotechnology-derived potatoes

that are no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions 

of the Plant Protection Act. 

1.1.1 The APHIS Regulatory Authority

The Plant Protection Act (PPA) authorizes and mandates APHIS to regulate, manage and control plant 

pests. This directive includes regulatory authority over the introduction (i.e., importation, interstate 

movement, or release into the environment) of certain GE organisms and products. A GE organism is no 

longer subject to the plant pest provisions of the PPA or to the regulatory requirements of 7 CFR part 

340, when APHIS determines that it is unlikely to pose a plant pest risk. A GE organism is considered a 

regulated article if the donor organism, recipient organism, vector, or vector agent used in engineering 

the organism belongs to one of the taxa listed in the regulation (7 CFR 340.2) and is also considered a 

plant pest. A GE organism is also regulated under 7 CFR 340 when APHIS has reason to believe that the 

GE organism may be a plant pest, or APHIS does not have information to determine if the GE organism is 

unlikely to pose a plant pest risk.

1 Referred to as the JR Simplot Company or Simplot hereinafter

1

 
A person may petition the agency for a determination that a particular regulated article is unlikely to 

pose a plant pest risk, and therefore, is no longer regulated under the plant pest provisions of the PPA or 

the regulations at 7 CFR 340. Under § 340.6(c)(4), the petitioner must provide information related to 

plant pest risk that the agency can use to determine whether the regulated article is unlikely to present 

a plant pest risk. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or 

the plant pest provisions of the PPA when APHIS determines that it is unlikely to pose a plant pest risk.

1.1.2 Purpose of this Product

Simplot InnateTM potato is genetically engineered to exhibit low acrylamide potential in cooked potatoes

and reduced black spot bruise. Acrylamide is a human neurotoxicant and potential carcinogen that may 

form in potatoes and other starchy foods under high-temperature cooking conditions2

. Black spot 

bruise is a post-harvest physiological disorder primarily resulting from the handling of potato tubers 

during harvest, transport, and processing, and refers to the black or grayish color which may form in the 

interior of damaged potatoes. 

The 10 Simplot InnateTM potato events were produced by using Agrobacterium-mediated transformation 

of potato internode explants of 5 different varieties: Ranger Russet, Russet Burbank, Atlantic, variety G 

and variety H (Simplot, 2013b). The binary plasmid vector pSIM1278 (Simplot, 2013b), consisting of the 

vector backbone (Simplot, 2013b) and the DNA insert (Simplot, 2013b) was used to create all 10 events; 

only the DNA insert portion was intended to be transferred to the recipient plants. The DNA insert in 

plasmid pS2IM1278 is designed to silence four different genes in the potato: asparagine synthetase-1 

(Asn1), polyphenol oxidase-5 (Ppo5), potato phosphorylase L (PhL) and the starch-associated R1 gene 

(R1). The suppression of Asn1 is anticipated to result in potatoes with reduced free asparagine, and the 

suppression of PhL and R1 is anticipated to result in potatoes with a lower content of reducing sugars. 

The gene targets of these four silencing constructs have been well-studied in potato and/or other plant 

species (Simplot, 2013a; USDA-APHIS, 2013a). Collectively, the silencing of these 3 genes should result 

in potato tubers with a reduced acrylamide potential. The suppression of Ppo5 confers the Simplot 

InnateTM potato with a non-browning phenotype resulting in tubers with reduced black spot bruising. 

Black spot bruise can lead to economic losses as high as 20 % (Partington et al., 1999); the potato 

industry therefore has a vested interest in minimizing these losses. Bachem et al. (1994) demonstrated 

that black spot bruise can be reduced by silencing Ppo genes in potatoes, and Simplot has further 

developed this concept in the design of Simplot InnateTM potato (Simplot, 2013b).

The intended purpose of the 10 Simplot InnateTM potato lines is to provide the potato processing 

industry with new varieties with low acrylamide potential and reduced black spot bruise. Both of these 

changes are intended to benefit potato consumers, producers, and processors. The low acrylamide 

2 e.g., frying 

2

 
potential is intended to benefit consumers because of concerns about the health effects of ingesting 

acrylamide (FDA, 2013b). Simplot InnateTM potatoes may offer an efficient method to reduce acrylamide 

in the diet. The reduced black spot bruise trait is intended to benefit consumers by providing a higher 

quality product, to benefit producers by reducing culls at delivery, and to benefit processors by reducing 

wastage.

Simplot InnateTM potato tubers are nutritionally and compositionally similar to their respective parental 

varieties and/or other commercial potato varieties, with the exception of the intentional changes 

conferred by the introduced genes. These intentional changes fall into three broad categories: (1) 

reduction of PPO enzyme levels in tubers; (2) alteration of the levels of asparagine and glutamine in the 

pool of free amino acids in tubers; and (3) reduction in the levels of the reducing sugars glucose and 

fructose in tubers (USDA-APHIS, 2013a).

1.2 Coordinated Regulatory Framework for Genetically-Engineered Organisms

The U.S. government has regulated GE organisms since 1986 under Federal regulations published in the 

Federal Register (51 FR 23302; 57 FR 22984) entitled “The Coordinated Framework for the Regulation of 

Biotechnology” (henceforth referred to here as the Coordinated Framework). The Coordinated 

Framework, published by the Office of Science and Technology Policy, describes the comprehensive 

Federal regulatory policy for ensuring the safety of biotechnology research and products. It also 

explains how Federal agencies will use existing Federal statutes to ensure public health and 

environmental safety while maintaining regulatory flexibility to avoid impeding the growth of the 

biotechnology industry. The Coordinated Framework is based on several important guiding principles: 

(1) agencies should define those transgenic organisms subject to review to the extent permitted by their 

respective statutory authorities; (2) agencies are required to focus on the characteristics and risks of the 

biotechnology product, not the process by which it was created; (3) agencies are mandated to exercise 

oversight of GE organisms only when there is evidence of “unreasonable” risk.

The Coordinated Framework explains the regulatory roles and authorities for the three major agencies 

involved in regulating GE organisms: USDA APHIS, the Environmental Protection Agency (EPA), and the 

Food and Drug Administration (FDA). A summary of each role follows.

1.2.1 USDA-APHIS

APHIS regulations at 7 Code of Federal Regulations (CFR) part 340, which were promulgated pursuant to 

authority granted by the PPA, as amended (7 United States Code (U.S.C.) 7701–7772), regulate the 

introduction (importation, interstate movement, or release into the environment) of certain GE 

organisms and products. A GE organism is no longer subject to the plant pest provisions of the PPA or to 

the regulatory requirements of 7 CFR part 340 when APHIS determines that it is unlikely to pose a plant 

pest risk. A GE organism is considered a regulated article if the donor organism, recipient organism, 

vector, or vector agent used in engineering the organism belongs to one of the taxa listed in the 

regulation (7 CFR 340.2) and is also considered a plant pest. A GE organism is also regulated under Part 

3
340 when APHIS has reason to believe that the GE organism may be a plant pest or APHIS does not have 

information to determine if the GE organism is unlikely to pose a plant pest risk. 

A person may petition the agency for a determination that a particular regulated article is unlikely to 

pose a plant pest risk, and, therefore, is no longer regulated under the plant pest provisions of the PPA 

or the regulations at 7 CFR 340. Under § 340.6(c)(4), the petitioner must provide information related to 

plant pest risk that the agency may use to determine whether the regulated article is unlikely to pose a 

plant pest risk. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or 

the plant pest provisions of the PPA when APHIS determines that it is unlikely to pose a plant pest risk.

1.2.2 Environmental Protection Agency

The EPA is responsible for regulating the sale, distribution, and use of pesticides, including those that are 

expressed by an organism modified using techniques of modern biotechnology. Such pesticides are 

regulated by EPA as plant-incorporated protectants (PIPs) under the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq.). EPA also regulates certain biological control organisms 

under the Toxic Substances Control Act (15 U.S.C. 53 et seq.). Before planting a crop containing a PIP, a 

company must seek an experimental use permit from EPA. Commercial production of crops containing 

PIPs for purposes of seed increase and sale requires a FIFRA Section 3 registration with EPA. 

Under FIFRA (7 U.S.C. 136 et seq.), EPA requires registration of all pesticide products for all specific uses

prior to distribution for sale. Before granting a registration, EPA evaluates the toxicity of the ingredients 

of pesticide product; the particular site or crop on which it is to be used; the amount, frequency, and 

timing of its use; storage and disposal requirements. Prior to registration for a new use for a new or 

previously registered pesticide, EPA must determine through testing that the pesticide does not cause 

unreasonable adverse effects on humans, the environment, and non-target species, when used in 

accordance with label instructions. EPA must also approve the language used on the pesticide label in 

accordance with 40 CFR part 158. Once registered, a pesticide may only be legally used in accordance 

with directions and restrictions on its label. The purpose of the label is to provide clear directions for 

effective product performance, while minimizing risks to human health and the environment. The Food 

Quality Protection Act (FQPA) of 1996 amended FIFRA, enabling EPA to implement periodic registration 

review of pesticides to ensure they are meeting current scientific and regulatory standards of safety and 

continue to have no unreasonable adverse effects (US-EPA, 2011d).

EPA also sets tolerances (maximum residue levels) or establishes an exemption from the requirement 

for a tolerance, under the Federal Food, Drug, and Cosmetic Act (FFDCA). A tolerance is the amount of 

pesticide residue that can remain on or in food for human consumption or animal feed. Before 

establishing a pesticide tolerance, EPA is required to reach a safety determination based on a finding of 

reasonable certainty of no harm under the FFDCA, as amended by the FQPA. FDA enforces the pesticide 

tolerances set by EPA.

4
The ten Simplot InnateTM potato events are not engineered to express substances to protect the 

potatoes against plant pests, and are therefore not subject to EPA review.

1.2.3 Food and Drug Administration 

FDA regulates GE organisms under the authority of the FFDCA (21 U.S.C. 301 et seq.). The FDA published 

its policy statement concerning regulation of products derived from new plant varieties, including those 

derived from genetic engineering, on May 29, 1992 (57 FR 22984). Under this policy, FDA implements a 

voluntary consultation process to ensure that human food and animal feed safety issues or other 

regulatory issues, such as labeling, are resolved before commercial distribution of food derived from GE 

products. This voluntary consultation process provides a way for developers to receive assistance from 

FDA in complying with their obligations under Federal food safety laws prior to marketing.

In June 2006, FDA published recommendations in “Guidance for Industry: Recommendations for the 

Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended 

for Food Use” (US-FDA, 2006). This establishes voluntary food safety evaluations for new non-pesticidal

proteins produced by new plant varieties intended to be used as food, including GE plants. Early food 

safety evaluations help make sure that potential food safety issues related to a new protein in a new 

plant variety are addressed early in development. These evaluations are not intended as a replacement 

for a biotechnology consultation with FDA, but the information may be used later in the biotechnology 

consultation.

The J.R. Simplot Company submitted a letter of consultation on February 12, 2013, which FDA is still 

reviewing (BNF No. 141).

1.3 Purpose and Need for This APHIS Action

APHIS responds to petitioners that request a determination of the regulated status of GE organisms (7 

CFR 340.6), including GE plants such as Simplot InnateTM potato. When a petition for nonregulated 

status is submitted, APHIS determines if the GE organism poses a plant pest risk. Under § 340.6(c)(4), 

the petitioner is required to provide information related to plant pest risk that the agency may use to 

determine whether the regulated article is unlikely to pose a plant pest risk. A GE organism is no longer 

subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the PPA when 

APHIS determines that it is unlikely to pose a plant pest risk.

In this EA, APHIS is responding to a petition from Simplot requesting a determination of nonregulated 

status for Simplot InnateTM potato. APHIS considers the potential environmental effects of an agency 

determination of nonregulated status of Simplot InnateTM potato consistent with regulations for 

implementing the National Environmental Policy Act (NEPA; 40 CFR parts 1500-1508), and the APHIS 

NEPA-implementing regulations and procedures (7 CFR part 1b, and 7 CFR part 372). This EA specifically 

evaluates the effects on the quality of the human environment that may result from a determination of 

nonregulated status for Simplot InnateTM potato.

5
1.3.1 Public Involvement

APHIS routinely seeks public comment on EAs prepared in response to petitions seeking a determination 

of nonregulated status of a regulated GE organism. APHIS does this through a notice published in the 

Federal Register. Through a March 6, 2012 notice published in the Federal Register3

, APHIS 

implemented changes to the way it solicits public comment when considering petitions for 

determinations of nonregulated status for GE organisms. The purpose of this change was to allow early 

public involvement in the process. As identified in this notice, APHIS publishes two separate notices in 

the Federal Register for petitions for which APHIS prepares an EA. The first notice announces the 

availability of the petition; the second announces the availability of the APHIS decision-making 

documents. The new process allows for public involvement by establishing a comment period after 

each of the two notices published in the Federal Register.

First Opportunity for Public Involvement:

Once APHIS judges a petition complete, a 60-day comment period is established for the public to submit 

comments to assist the Agency in the development of it EA and PPRA. The availability of the petition for 

public comment is announced in a Federal Register notice.

Second Opportunity for Public Involvement

The draft PPRA and draft EA are developed, and a notice of their availability is published in a second 

Federal Register notice. This second notice follows one of two approaches for public participation based 

on whether or not APHIS determines the petition for nonregulated status for a GE organism involves 

substantive new issues: 

Approach 1. For GE organisms that do not involve substantive new issues

This is used when APHIS determines, based on a review of the petition and its evaluation and analysis of 

public submissions received during the 60-day comment period for the petition, that the GE organism 

does not involve new biological, cultural, or ecological issues. Agency criteria for this decision include a 

determination that the nature of the modification is not novel or that the Agency has a high degree of 

familiarity with the organism through previous regulatory actions, or both. After this determination is 

3

This notice can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2012-03-06/pdf/2012-5364.pdf

6

 
made, APHIS conducts the necessary analysis and prepares its PPRA, EA, and finding of no significant 

impact (FONSI). Once completed, APHIS publishes a notice in the Federal Register announcing its 

preliminary regulatory determination and the availability of the EA, FONSI, and PPRA for a 30-day public 

review and comment period.

Unless information received in public comments warrants substantially changing the PPRA or EA analysis 

and determination, the Agency’s preliminary regulatory determination becomes effective. No further 

Federal Register notices are published announcing the final regulatory determination. The Agency posts

this public notification in an announcement on the APHIS website.

Approach 2. For GE organisms involving substantive new issues not previously analyzed 

This protocol is used when a petition is for nonregulated status for a novel GE organism. A novel 

organism is one that is not identical with or sufficiently similar to organisms determined previously by 

APHIS to have nonregulated status. Examples include organisms with new gene modifications that 

could have substantial biological, cultural, or ecological effects not previously analyzed. For this process, 

APHIS prepares drafts of a PPRA and an EA, and then solicits further comments during a 30-day period 

that is announced in a Federal Register notice. APHIS reviews and evaluates comments and other 

relevant information. APHIS then revises the PPRA as necessary and prepares a final EA. Following 

preparation of these documents, APHIS approves or denies the petition, then announces its decision in 

the Federal Register, and provides notice of the availability of the final EA, PPRA, NEPA decision 

document, and regulatory determination.

More details about this expansion of opportunities for stakeholder review and comment are available in 

the Federal Register notice published on March 6, 20124

.

1.3.2 Public Involvement Approach for This EA

APHIS has determined that the protocol for preparation of this EA will follow Approach 2. The issues 

considered in this EA were developed by reviewing the public concerns, including public comments

received in response to the Federal Register notice on May 3, 2013 (78FR 25942-25943) announcing the 

availability of the petition (i.e., the first opportunity for public involvement previously described in this 

document). The Agency also considered public comments submitted for other EAs of GE organisms, and 

concerns described in lawsuits or expressed by various stakeholders. These issues, including those 

regarding the agricultural production of Simplot InnateTM potato using various production methods and 

the environmental and food/feed safety of GE plants, were addressed to analyze the potential 

environmental impacts of Simplot InnateTM potato.

4

This notice can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2012-03-06/pdf/2012-5364.pdf

7

 
The public comment period for the review of this petition for nonregulatory status of Simplot InnateTM

potato closed on July 2, 2013. At its closing, the docket file contained a total of 308 public comments. 

These were screened and sorted into categories according to the subject matter addressed (e.g., air, 

water, soil impacts), and classified as either non-substantive or substantive. Most of the comments that 

expressed a general dislike of the use of GE organisms were considered non-substantive because they 

did not express an issue APHIS could address. One comment from a non-governmental organization 

(NGO) had 41,475 signatures appended to it.

Eighty-five of the comments supported the petition, citing potential improved health benefits to 

consumers and decreased wastage of potato as economically beneficial to the potato industry.

The majority of the negative comments expressed a general dislike of the use of GE organisms. This 

issue is outside the scope of this EA. 

The issues that were raised in the public comments which were related to the Simplot InnateTM potato 

petition included: 

• Contamination of conventional potato production.

• Concerns that more research should be done prior to approval of the petition.

• Concerns that plant fitness will be negatively affected.

• Impact that petition approval may have on export markets.

APHIS has analyzed and evaluated the issues described in these comments, and has included a 

discussion of these issues in this EA with citations where appropriate.

Additionally, on May 30, 2014, APHIS published a notice in the Federal Register (78 FR 31080-31082, 

Docket no. APHIS-2012-0067) announcing the availability of the Simplot InnateTM potato draft EA (13-

022-01p) and draft PPRA for a 30-day public review and comment period. Comments were required to 

be received on or before June 30, 2014.

A total of 60 public comments were received subsequent to the draft EA publication. The majority of 

those public comments supported the determination of nonregulated status; however, some public 

comments did not support the determination of nonregulated status. Supporting commenters included 

individuals from 7 different universities, three trade associations, one industry organization, and 10 

farmers. 

Of the public comments which opposed nonregulated status for InnateTM potato, the majority of these 

public comments did not explain or identify elements in the InnateTM potato PPRA or EA that were 

perceived to be inadequate or provide any supporting evidence for their claims. 

Three of the dissenting comments did not contain a letter, but only attached publications and articles. A 

fourth dissenting comment contained a letter to which 35, 451 signatures of citizens were appended.

8
APHIS carefully reviewed the articles sent in by commenters. Many of them were included in the EA, 

many of them pertained to other dockets, but none contributed any new information relevant to 

InnateTM potato.

1.4 Issues Considered

The list of resource areas considered in this EA was developed by APHIS through experience in 

considering public concerns and issues identified from public comments submitted for this petition and 

other EAs of GE organisms. The resource areas address concerns raised in previous and unrelated 

lawsuits, as well as issues that have been raised by various stakeholders for this petition and in the past. 

The resource areas considered in this EA can be categorized as follows: 

Agricultural Production Considerations:

• Land Use of Potato Production

• Agronomic/Cropping Practices

• Potato Seed Production 

• Organic Potato Production 

Environmental Considerations:

• Water Resources

• Soil

• Air Quality 

• Climate Change

• Animals

• Plants

• Gene Flow

• Microorganisms

• Biological Diversity

Human Health Considerations:

• Public Health

9
• Worker Safety

Livestock Health Considerations:

• Livestock Health/Animal Feed

Socioeconomic Considerations:

• Domestic Economic Environment 

• Trade Economic Environment

APHIS evaluated these raised issues and the submitted documentation. APHIS has also included a 

discussion of these issues in this EA.

10
2 AFFECTED ENVIRONMENT

This section includes a review of the prevailing conditions of the human environment that may be 

impacted by Simplot InnateTM potato production. Relevant environmental components include 

agricultural production area of Simplot InnateTM potato, the physical environmental, biological resources, 

human health, animal feed, and socioeconomic resources.

2.1 Agricultural Production and Agronomic Practices of Potato

Potato is the fourth most important crop in the world in terms of human consumption, following rice, 

wheat, and maize (corn) (Arvanitoyannis et al., 2008; Llorente et al., 2011). Potato is grown in over 100 

countries, with world potato production exceeding 300 million metric tons (IPC, 2010).

2.1.1 Land Use

Potatoes are grown across most of the continental United States, with seven States (Colorado, Idaho, 

Minnesota, North Dakota, Oregon, Washington and Wisconsin) accounting for approximately 77% of 

annual production (USDA-APHIS, 2013a) (Figure 1). Within recent years, land devoted to potato 

production has shifted from the East and Midwest to the Pacific Northwest. This shift has resulted from 

a number of factors, including improvements in the U.S. transportation system, the relative decline in 

consumption of fresh potatoes coupled with advantages associated with processing potatoes in the 

Northwest such as lower taxes, and lower power and labor costs, more favorable weather, and available 

land for acreage. The largest potato-growing region by far in the United States is the Snake River Plain 

of southern Idaho, a major agricultural area where water is available for irrigation, where nearly all the 

Idaho crop is grown (Bechinski et al., 2001; USDA-NASS, 2012c). The second-largest growing region is 

the Columbia Basin in Washington and Oregon, where approximately 137,000 acres were harvested in 

2010 (USDA-NASS, 2012c). Other important areas (with 2010 harvested acreage in parentheses) are the 

Red River Valley, which lies between the northern borders of North Dakota and Minnesota (63,000); San 

Luis Valley in south central Colorado (55,200), Aroostook County in Maine (50,400), and the Central 

Sands region of Wisconsin (36,700) (USDA-NASS, 2012c). Simplot InnateTM potato events may be grown 

in any of the U.S. potato-growing regions.

11
Figure 1. Potato Growing Regions of the United States (USDA-NASS, 2007)

Potato acres harvested in the United States have ranged between 1.0 and 1.5 million acres since 1951, 

with highs of 1.5 million in 1953, 1966 and 1967, and lows of 1.0 million in 2008, 2009 and 2010 (USDANASS, 2012c). In most years from 1900 to 1937, more than 3 million acres were harvested, with a high 

of 3.9 million in 1922 (USDA-NASS, 2012c). While harvested acreage has declined over the years, total 

production has increased (Guenther, 2010a). For example, in the 1930s, from about 3.5 million acres of 

potatoes were harvested, whereas by 1985, production had nearly doubled on less than half the acreage 

of the 1930s, and by 2005, acreage had declined to about 1 million acres, less than 1/3 the 1930s 

acreage (Guenther, 2010a). Total annual U.S. production has been over 400 million cwt (one cwt = 100 

pounds) every year since 1990, with a peak of 513,544,000 cwt in 2000 (USDA-NASS, 2012c). Per-acre 

yields, which averaged approximately 336 cwt per acre in 2012, have increased seven-fold since the 

early 1900s and have doubled since the early 1960s. For example, in 1901 approximately 2.95 million 

acres of potatoes were harvested, producing roughly 125 million cwt, or 46.6 cwt per acre (USDA-NASS, 

2012c; 2013b). 

The top ten potato producing states shown in Table 1 account for almost 83% of the United States 

potato crop (USDA-NASS, 2013a). Highest yields are in regions where daytime temperatures exceed

100° F during the hottest part of growing season, and where nights are cool (about 65° F), such as in 

Washington’s Columbia Basin, eastern Oregon, California, and Nevada (Rosen, 2010d).

12
Table 1. Major Potato Production States

State Production (1,000 cwt) Percent of Total 

U.S. Production

Idaho 141,820 30.6

Washington 95,940 20.7

Wisconsin 29,440 6.4

North Dakota 25,200 5.4

Colorado 23,365 4.8

Minnesota 18,800 4.1

Michigan 15,925 3.4

Maine 15,675 3.4

California 15,501 3.3

Oregon 2,236 0.4

Source: (USDA-NASS, 2013a)

Most potatoes are harvested in July through October. Fall crops have increased because of demand for 

processing (Guenther, 2010a). Harvested potatoes are either used for food (~93%), feed (<1%), 

industrial purposes (<1%) or as “seed” for planting (5%) (NPC, 2012; USDA-NASS, 2013a). Usage is 

partially dependent on a variety of characteristics related to tuber quality. Only about one quarter of 

U.S. potatoes are consumed fresh (USDA-NASS, 2013a), while approximately 60% of annual output is 

processed into frozen products (such as frozen fries and wedges), chips, dehydrated potato and starch

(11%), canned potatoes (0.4%), and 6% is replanted as seed potato. Americans eat, on average, 

approximately 112 lbs. (51 kg) of potatoes per person per year (NPC, 2012). 

Raw potato waste products (peels, out of specification raw potatoes, or other non-processed raw potato 

products) and processed discards (French fries, hash brown, etc.) are routinely incorporated into feed 

rations at livestock feedlot operations (Simplot, 2013a).

U.S. 2012 potato harvests by state are summarized in Table 2 (in acres). 

13
Table 2. U.S. 2012 Potato Harvest by State

State Acres Of Potato Harvested

Idaho 344,000

Washington 164,000

North Dakota 84,000

Wisconsin 64,000

Colorado 59,300

Maine 57,000

Minnesota 47,000

Michigan 45,500

Oregon 41,700

California 37,300

Florida 36,600

Nebraska 23,300

Texas 20,100

New York 16,500

North Carolina 16,000

Montana 11,700

Missouri 8,900

Pennsylvania 8,700

Illinois 7,400

Kansas 5,200

Virginia 4,800

Massachusetts 3,900

Arizona 3,700

14
Total 1,134,550

Source: (USDA-NASS, 2013b)

2.1.2 General Agronomic Practices 

USDA classifies potato production by season, according to the period when the largest supplies are 

harvested. Winter, spring and summer potatoes are harvested while the vines are still green and the 

tubers comparatively immature. These potatoes go directly from the field to fresh markets or into 

processing. 

Fall potatoes are usually harvested when the vines and tubers are mature. Mature potatoes are usually 

higher in dry matter, which makes them better for most processing, and also have tougher skins, which 

makes them easier to handle (Johnson, 2010). A large percentage of the fall crop is stored for 

processing and fresh market through the winter, spring and summer months. Many modern storage 

facilities are equipped with temperature, humidity, and forced-air ventilation control. Capacity can 

range from 500 tons to over 20,000 tons (Olsen, 2010).

Proper water management is integral to obtaining optimum quality and yield since potatoes are more 

sensitive to water stress than some other crops. Potatoes have a relatively shallow root-zone depth, 

and are frequently grown on soils with only fair water-holding capacities (King and Stark, No Date).

The easternmost regions of the United States generally receive enough rainfall in order to produce good 

quality and yield of potatoes, whereas the western part of the country typically relies on some form of 

irrigation. Specific guidelines for irrigation depend on geographic region and factors typical of that 

region such as temperature, relative humidity, and day length. Water requirements also vary to some 

degree with cultivar. Most potato-growing regions require between 18 and 36 in. of water to produce 

an optimum crop. Enough moisture to keep plant stomata open during the hottest part of the day is 

critical (Shock, 2010).

In regions where rainfall is the primary source of water, growers may increase water use efficiency by 

avoiding steeply sloping fields for planting, and by preparing the soil so that infiltration of water is 

increased, and by also making ridges in the furrows to mitigate the amount of water running off the field 

(Shock, 2010).

Timing of water application and amount of water delivered are important to potato production. Some 

physical defects, such as growth cracks, hollow heart, black spot, and knobby tubers, are directly related 

to amount and distribution of water during the growing season. Excessive water may result in yield 

reduction and diseases such as Rhizoctonia stem canker, scab, and tuber late blight (DEFRA, 2006; 

Shock, 2010; King and Stark, No Date). Too little water at the time of tuber initiation can lead to a 

reduced number of tubers (DEFRA, 2006). Daily water needs increase from emergence of plants to 

15
approximately two weeks after row closure, but then decline rapidly after onset of vine maturation

(DEFRA, 2006; Shock, 2010). Potatoes need more water during tuber initiation and early tuber 

development. At harvest, soil water content is also important to reduce mechanical damage to tubers 

which are frequently associated with dehydration such as black spot bruise, and excess water such as 

shatter bruise and thumbnail cracking (DEFRA, 2006; King and Stark, No Date).

Potato Breeding

The tetraploid nature of commercial potato varieties is a significant impediment to potato breeding, as 

well as biological factors such as inbreeding depression, and cytoplasmic and nuclear sterility (Hoopes 

and Plaisted, 1987; Arvanitoyannis et al., 2008). Due to complex chromosome segregation ratios, 

polyploid crops are inherently more difficult to breed. Furthermore, vegetatively propagated crops like 

potato are often poor seed producers due to partial or full sterility. For seed propagated crops, like corn 

or soybean, trait developers often create a single elite event and then backcross that elite event into a 

wide range of elite germplasm. This is not possible in potato. Each parent variety must be 

independently transformed to achieve the desired phenotype in that variety (USDA-APHIS, 2013a). If a 

single variety was transformed, it could take decades to move these new traits into the other 

commercial varieties by conventional breeding, and even then, it would be difficult to reconstitute the 

desirable characteristics of the original variety (Llorente et al., 2011; USDA-APHIS, 2013a).

Because maintenance of a vegetatively propagated, disease- and insect-free genetic stock is difficult, 

much of the genetic base is kept as true seed populations (Spooner, 2010).

Cultivation 

Potatoes typically require high levels of soil cultivation (Hopkins et al., 2004), which helps with weed 

control, aeration, shaping beds, maintaining proper seed depth and establishing irrigation furrows

(Bechinski et al., 2001; Sieczka, 2010). Potato production is generally not conducive to maintaining 

healthy soil conditions, because of intensive tillage, minimal crop residues left on the field, heavy field 

traffic and long periods of soil being left bare (Hopkins, 2010). In the Northwest, potato fields are 

typically tilled both before and after the season (Hopkins et al., 2004). In the Red River Valley, between 

North Dakota and Minnesota, a common practice just before planting is to plow once in the fall, till two 

or more times during the winter, and disc the field in the spring (USDA, 2000).

Cover Crops

In potato production, a fall cover crop is frequently planted in order to reduce erosion from fields 

(Sexton, 2010). Subsequent to mowing the cover crop, the residues may be left on the field to minimize 

wind erosion (Rosen, 2010b). Another method of reducing erosion as well as mitigated disease pressure 

is to till green manure crops into the soil prior to planting (Hopkins et al., 2004). Growers in Florida use 

Sudan grass as a cover crop to provide nitrogen prior to potato planting (Mossler and Hutchinson, 2011).

Growing cover crops can also increase yield of the subsequent cash crop (Cornell University, 2013).

16
Crop Rotation

One of the challenges that growers face is the high short-term economic demand for potatoes to be 

grown continuously, partly because of the investment that is put into the specialized equipment used in 

potato growing, and because potatoes represent the highest potential gross return per acre (Hopkins et 

al., 2004). Continuous cropping, and short rotations of this crop along with others, causes potato crops 

to become more susceptible to complications and increases the risk of insect, disease, and nematode 

pressure, decrease in soil nutrient levels, and an increase in erosion potential (Delahaut, 2000; Hall et 

al., 2000; Bennett and O'Rourke, 2002; Larkin, 2003; Hopkins et al., 2004). Lower microbial biomass 

occurs in fields where continuous cropping is practiced, compared to fields where crops are rotated 

(Larkin, 2003). Therefore, frequent rotation of other crops with potatoes is recommended (Hopkins, 

2010; Cornell University, 2013) in order to increase yield and to reduce insect and disease pressure, as 

well as to reduce the population density of weeds. Farmers are also advised to avoid planting potatoes 

near fields where potatoes were planted the previous year. Rotation crops vary with geographical 

region: for example, in Idaho, potatoes are rotated with small grains, sugar beets, alfalfa, dry beans and 

corn (Hopkins et al., 2004); with grains in the Red River Valley in North Dakota and Minnesota (USDA, 

2000); with malting barley in the San Luis Valley in Colorado (McDonald et al., 2003); and corn, small 

grains, legumes and green manure crops in Wisconsin (Delahaut, 2000). 

Insect Control

The potato crop is intensively managed with integrated pest management (IPM) to control a variety of 

insect and disease (Johnson, 2007). More than 150 species of insects may damage potatoes, most of 

which cause only minor economic injury. However, several species cause economic injury through 

feeding on foliage, tubers, or roots, or by transmitting disease pathogens to the plant. While major 

insect pests vary within production regions, the most serious overall is the Colorado potato beetle. In 

the eastern U.S., leafhoppers can also cause yield loss to plants before plants present any visual 

symptoms of feeding damage; several leafhopper species are serious problems because they vector 

phytoplasmas (Radcliffe, 2010). Aphid-transmitted diseases cause greater economic losses than all other 

insect damage combined together. At least 9 potato viruses are transmitted via aphids, the most 

important of which is potato leaf roll virus (PLRV), vectored primarily by green peach aphid, and potato Y 

virus (PVY), vectored by potato aphid, pea aphid, melon aphid, buckthorn-potato aphid, soybean aphid,

and bird cherry-oat aphid (Radcliffe, 2010; Rondon, 2012). Occasional pests include armyworm, loopers, 

cutworms, and spider mites (Rondon, 2012).

Some soil insects can cause a decrease in quality of tubers, but generally cause little decrease in yield. 

The most important of these are wireworms, the larval stage of elaterid beetles (Bechinski et al., 2001), 

particularly if fields are laden with sod sometime before planting (Roberts and Cartwright, No Date).

Growers may also mitigate insect pressure by avoiding planting on fields nearby cornfields since 

European corn borer may also infest potato (Cornell University, 2013). Insect pests in stored corn 

17
include potato tuber moth, Phthorimaea operculella, and seed corn maggot, Delia platura (Rondon, 

2012).

Table 3. Major Insect Pests of Potato 

Common Name Scientific Name

Colorado potato beetle Leptinotarsa decemlineata

Green peach aphid Myzus persicae

Wireworms Limonius californicus, L. canu, 

Ctenicera pruinera

Potato leafhopper Emposasca fabae

Pea aphid Acyrthosiphon pisum

Soybean aphid Aphis glycine

Thrips Franklinella spp., Thrips spp.

Flea beetle Epitrix spp.

European cornborer Ostrinia nubilalis

Potato psyllid Bactericera (Paratrioza) cockerelli

Potato Tuberworm or Tuber 

Moth Phthorimaea operculella

Sources: (Radcliffe, 2010; Rondon, 2012; Roberts and Cartwright, No Date)

Disease Control

Potato diseases can be caused by viruses, viroids, phytoplasmas, and most importantly, by bacteria and 

fungi. Infection can occur when cutting potatoes into seed pieces prior to planting, in which a disease 

organism present in the seed potato is transmitted to the resulting potato plant. The cut surfaces of the 

seed pieces, until they are suberized, are open wounds that provide a route of entry for pathogens 

(Davidson, 2010).

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Potatoes can become infected with a number of viruses (e.g. potato leafroll virus, and potato viruses A, 

M, X and Y); however, IPM options for virus pests are limited to insecticidal control of their insect 

vectors and planting of resistant varieties, including some GE varieties (Arif et al., 2012; USDA-APHIS, 

2013a).

There are several factors to consider in controlling potato diseases, including part of the plant being 

attacked, pathogen transmission mechanism, and environmental conditions. Table 4 lists the major 

diseases of potato. Some of these are more common while plants are in the field, while others only 

emerge during storage (Bechinski et al., 2001). Growers may plant disease-resistant cultivars, use 

certified seed, spray fungicides, and rotate potato with other crops in order to mitigate disease pressure 

(Johnson et al., 2010; Hollingsworth, No Date). 

Table 4. Major Diseases of Potato

Common Name Scientific Name

Bacteria

Aster Yellows MLO Member of Acholeplasmataceae

Bacterial ringrot Corynebactium sepedonicum

Bacterial brown rot Ralstonia solanacearum

Bacterial soft rot Pectobacterium carotovorum

Blackleg Erwinia carotovora

Golden nematodes Globodera rostochiensis

Potato tuber rot Ditylenchus destructor

Root knot Meloidogyne spp.

Columbia root knot Meloidogyne chitwoodi

Root lesion Pratylenchus penetrans

Viruses

Potato Leafroll Virus Luteovirus

19
Common Name Scientific Name

Potato Spindle Tuber Viroid Member of Pospiviridae

Potato Virus A,M, X, Y Members of Potyviridae, Carlavirus, 

Tobacco Rattle Virus Tobravirus

Fungi

Late blight Phytophora infestans

Pink rot Phytophthora erythroseptica

Early dying Verticillium spp.

Sclerotinia stalk rot or white 

mold

Sclerotinia sclerotiorum

Canker or black scurf Rhizoctonia solani

Scab Streptomyces scabies

Dry rot Fusarium spp.

Fusarium wilt

Fusarium solani var eumartii, 

Fusarium oxysporum

Water or shell rot Pythium ultimum

Early blight Alternaria solani

Gray mold Botrytis cinerea

Black dot Colletotrichum coccodes

Ring rot Clavibacter michiganensis subsp.

Sepedonicus

Powdery scab Spongospora subterranea

Silver scurf Helminthosporium solani

Wart Synchytrium endobioticum

Nematodes

Golden nematodes Globodera rostochiensis

Potato tuber rot Ditylenchus destructor

20
Common Name Scientific Name

Root knot Meloidogyne spp.

Columbia root knot Meloidogyne chitwoodi

Root lesion Pratylenchus penetrans

Sources: (Johnson et al., 2010; Roberts and Cartwright, No Date)

Weed Management

Weeds pose a management issue for growers, potentially causing a significant loss in yield by

outcompeting potatoes for nutrients, water and sunlight. Tillage and herbicide usage can help control 

weeds (Delahaut, 2000; Hutchinson, 2010), although tillage can also damage potato plants and reduce 

yields. Common weeds in potato fields fall into three main classes: annual broadleaf plants, which are 

the easiest to control, with the exception of nightshade; annual grasses, which may germinate later than 

most broadleaf annuals; and perennials, which are the most difficult to control (Hutchinson, 2010; 

Cornell University, 2013). Major weed species in potato fields are noted in Table 5. In addition to 

competition with potato plants for resources, weeds are detrimental to the crop due to potential 

penetration of potato tubers by weed roots, causing a severe reduction in crop quality (Hutchinson, 

2010).

Table 5. Major Weeds of Potato 

Broadleaf Annuals Annual Grasses Perennials

Hairy nightshade (Solanum 

sarrachoides)

Common lambsquarters 

(Chenopodium album)

Redroot pigweed (Amaranthus 

retroflexus)

Ragweed (Ambrosia artemisiifolia)

Kochia (Kochia scoparia)

Barnyardgrass (Echinochloa crusgalli)

Foxtail (Setaria spp.)

Wild oat (Avena fatua)

Fall panicum (Panicum 

dichotomiflorum)

Nutsedges (Cyperus spp.)

Quackgrass (Elytrigia repens)

Canada thistle (Cirsium arvense)

21
Pennsylvania smartweed 

(Polygonum pennsylvanicum)

Source: (Hutchinson, 2010)

In order to mitigate weed problems, growers should avoid planting potatoes on fields with heavy 

infestations of weeds. Most growers also scout their fields to assess the need for herbicides, and choose 

rotational crops that compete successfully with weeds (Bechinski et al., 2001). 

Commonly used herbicides are metribuzin, EPTC, and metolochlor (USDA, 2000; Bechinski et al., 2001; 

McDonald et al., 2003). Growers may also rotate herbicide use according to chemical class in order to 

avoid or delay the development of weed resistance (Bechinski et al., 2001).

Volunteer Potatoes

Volunteer potatoes are tubers that are left in fields after a harvest, which compete with rotational crops 

for sunlight, water, and essential nutrients, and then compete with a subsequent potato crop. In 

addition to becoming weeds, volunteer potatoes can also be hosts for disease such as late blight, potato 

leaf roll, and virus Y (Eberlein et al., 1998; Boydston and Williams, 2005). Several herbicides can be used 

for the control of volunteer potato plants ((Boydston and Williams, 2005; Everman and Long, 2010). 

Other control measures may include post-harvest grazing and rotation to crops competitive with the 

volunteers (Eberlein et al., 1998). 

In general, potato is a poor colonizer in wild ecosystems. Outside agricultural fields, volunteer potato 

seedlings cannot compete well with other plants, and, therefore, are unlikely to establish themselves. 

During transportation and processing, there is a possibility of tubers being released, but again, there is 

little probability of successful establishment (OECD, 1997). 

Organic Potatoes

To bear a certified organic label, farms grossing more than $5,000/year in revenues must be certified by 

a USDA National Organic Program (NOP) accredited certifying agency. Certifying agencies also have 

specific cultural requirements with regard to field selection (e.g., fields cannot have been treated with 

prohibited chemicals for 3 years before harvest of a certified organic crop, and there must be sufficient 

buffer zones between certified organic crops and conventionally grown crops in order to reduce 

potential contamination between the two such as via pollination) (Cornell University, 2013). There are 

other requirements and recommended practices for organic potato production see, e.g., (Moore and 

Olsen, No Date) for organic potato production in Idaho, and (Hollingsworth, No Date) for organic potato 

production in California.

In terms of US organic potato production, measured in cwt/year, the leading states are Washington

(>600,000), Colorado (>500,000), California (>400,000), Oregon (>300,000), Idaho (>200,000), and much 

22
lesser amounts from Maine (>25,000), Wisconsin (>23,000), Ohio (>17,000), and Vermont (>7,000) 

(USDA-NASS, 2008). In terms of sales/year, the leading states are California (>$10 million), Colorado 

(>$6 million), Washington (>$4 million), Oregon (>$3 million), and Idaho and Maine (each state, >$1 

million) (USDA-NASS, 2008). As discussed in Section 2.3.1, Domestic Economic Environment, organic 

potatoes command a premium price compared to conventionally grown potatoes.

Potato Seed Production

Potatoes are vegetatively propagated by planting tubers or seed pieces (Davidson, 2010; NSF, 2011). In 

2012, approximately 6 percent of the 2012 annual potato crop was used as seed (NPC, 2012) in the form 

of seed potatoes. Certified seed potatoes are produced to ensure genetic purity and to reduce disease 

introduction (NPC, 2012). Most seed that is sold is labeled certified seed (USDA, 2000), which means 

that certification agency requirements must be met. These requirements include inspections of fields, 

storage facilities, and shipping points in order to evaluate whether disease incidence exceeds 

established thresholds (Moore and Olsen, No Date).

There are 16 potato seed certification agencies in the United States, including one in each major 

production state (NPC, 2012). Typically, seed potatoes are grown in the same areas where potatoes for 

commercial production are grown, although the areas of maximum seed production sometimes differ 

from the areas of maximum tuber production. Major seed production states in 2012 in order of 

decreasing production were Idaho (>35,000 acres harvested), North Dakota, Colorado, Maine, Wisconsin 

and Minnesota (>7,000 acres harvested) (USDA-NASS, 2013a).

The use of good quality seed potatoes is important to successful potato culture. It is recommended that 

seed size be ideally about two to four ounces, about the size of a golf ball (Hollingsworth, No Date).

Potato Processing and Storage

About 60% of potatoes are processed into frozen commodities such as French fries and shoestring 

potatoes and dehydrated. Typically, frozen and dehydration industries are concentrated in the 

Northeast, upper Midwest, and Pacific Northwest. Potato chip processers tend to be more evenly 

distributed throughout the country because chips are fragile, and long-distance shipping is expensive. 

Therefore, chipping plants tend to be located near heavily populated areas (Guenther, 2010b).

Long-term storage is needed for processing operations. Capacities of storage facilities typically range 

from 500 to >20,000 tons. Most of the tubers are kept in bulk piles, but some facilities use box storage. 

In northern production areas, a large percentage of the potato crop is stored for processing and fresh 

market uses during the winter, spring, and summer months. Storage facilities are frequently equipped 

with ventilation systems and systems to monitor temperature, relative humidity and carbon dioxide 

levels. Some storage facilities are refrigerated to cool stored potatoes during warmer spring and 

summer months (Olsen, 2010). Potatoes kept stored for > 130 days have a tendency to sprout, and are 

therefore chemically treated to prevent sprout formation (Kleinkopf, 2010). Prolonged storage can also 

23
lead to lowered tuber quality from moisture loss, which can cause tuber surface wrinkling 

(Arvanitoyannis et al., 2008).

2.2 Physical Environment

2.2.1 Water Resources

The principal law governing pollution of the nation’s water resources is the Federal Water Pollution 

Control Act of 1972, better known as the Clean Water Act (CWA). The Act utilizes water quality 

standards, permitting requirements, and monitoring to protect water quality. The EPA sets the 

standards for water pollution abatement for all waters of the United States under the programs 

contained in the CWA, but, in most cases, gives qualified states the authority to issue and enforce 

permits. Drinking water is protected under the Safe Drinking Water Act of 1974 (Public Law 93-523, 42 

U.S.C. 300 et seq.). 

Surface water in rivers, streams, creeks, lakes, and reservoirs supports everyday life through the 

provision of water for drinking and other public uses, irrigation, and industry. Surface runoff from rain, 

snowmelt, or irrigation water can affect surface water quality by depositing sediment, minerals, or 

contaminants into surface water bodies. Surface runoff is influenced by meteorological factors such as 

rainfall intensity and duration, and physical factors such as vegetation, soil type, and topography. 

Agricultural production, including potatoes, can adversely impact surface water quality, primarily 

through sedimentation from erosion and nutrient loading from fertilizers (US-EPA, 2005; 2009a). 

Nitrogen loss in the form of ammonium and nitrates to surface water can occur as a result of direct 

runoff, or by infiltration through the root zone, and discharge to surface water by drainage or seepage

(Zebarth et al., 1999).

Groundwater is the water that flows underground and is stored in natural geologic formations called 

aquifers. It sustains ecosystems by releasing a constant supply of water into wetlands and contributes a 

sizeable amount of flow to permanent streams and rivers. Based on 2005 data, the largest use of 

groundwater in the United States is irrigation, representing approximately 67.2% of all the groundwater 

pumped each day (McCray, 2009). In the United States, approximately 47% of the population depends 

on groundwater for its drinking water supply. The EPA defines a sole source aquifer (SSA) as an aquifer 

that supplies at least 50% of the drinking water consumed in the area overlying the aquifer. An SSA 

designation is one tool to protect drinking water supplies in areas where there are few or no alternative 

sources to the groundwater resource. There are 77 designated SSAs in the United States and its 

territories (US-EPA, 2011e). Crop production has the potential to impact groundwater in areas with 

shallow (less than approximately 15 feet deep) water tables through leaching of the nitrates from 

fertilizers fertilizers (Nolan et al., 2002; DEFRA, 2006). Agricultural production leads to nitrate 

contamination of groundwater through leaching associated with high applications of manure or 

fertilizers or excessive irrigation (Zebarth et al., 1999; DEFRA, 2006). 

24
Unlike a point source which is a “discernible, confined and discrete conveyance”, nonpoint source (NPS) 

pollution comes from many diffuse sources. Rainfall or snowmelt moving over the ground, also known 

as runoff, picks up and carries away natural and human-made pollutants, creating NPS. The pollutants 

may eventually be transported by runoff into lakes, rivers, wetlands, coastal waters and ground waters. 

Agricultural NPS pollution includes animal wastes, fertilizers, and pesticides. Surface water may be 

contaminated by agricultural sediments transported by erosion that may also include pesticides, 

fertilizers, and sometimes fuel and pathogens. Agricultural practices that introduce contaminants into 

the groundwater include fertilizer and pesticide application, spilled oil and gasoline from farm 

equipment, nitrates, and pathogens from animal manure.

NPS pollution is the leading source of water quality impacts on rivers and lakes, the second largest 

source of impairments to wetlands, and a major contributor to groundwater contamination (US-EPA, 

2005). Management practices that contribute to NPS pollution include the type of crop cultivated, 

plowing and tillage, and the application of pesticides, herbicides, and fertilizers. The primary cause of 

NPS pollution is increased sedimentation in surface waters following soil erosion (US-EPA, 2005). The 

major contribution to groundwater contamination derives from agricultural areas (nitrogen inputs from 

fertilizer and manure drainage and leaching from root-zone areas due to over-irrigation; and salts in the 

form of carbonates, sulfates, and chlorides, from drainage) and is influenced by regional environmental 

factors such as precipitation and soil characteristics (Skaggs et al., 1993; US-EPA, 2003; King and Stark, 

No Date). Nutrients applied in excess of recommended application rates are listed as the second cause 

of impairment in lakes, reservoirs, and ponds, with agriculture listed as the third most probable source 

of the impairment (US-EPA, 2012b).

Agricultural pollutants released by soil erosion include sediments, fertilizers, and pesticides that are 

introduced to area lakes and streams when they are carried off of fields by rain or irrigation waters (USEPA, 2005). Increase in sediment loads to surface waters can directly affect fish, aquatic invertebrates, 

and other wildlife maintenance and survival. It also reduces the amount of light penetration in water 

which directly affects aquatic plants. Indirectly, soil erosion-mediated sedimentation can increase 

fertilizer runoff, thereby increasing nutrient loading and facilitating higher water turbidity, algal blooms, 

and oxygen depletion (Skaggs et al., 1993; US-EPA, 2005). Over-fertilization should be avoided to 

prevent nutrient leaching into groundwater, risk of ground water pollution with nitrates, and risk of 

estuary pollution from nitrates and phosphates (Carroll and Robinson, 2006). Preservation and 

conservation of water and soil resources must be maximized and non-point-source pollution must be 

minimized (Carroll and Robinson, 2006).

Most of the potatoes produced in the United States are grown under irrigation, including potatoes 

grown in Idaho, Washington, Oregon, California, and Wisconsin, whereas rainfall provides adequate 

moisture for potato crops in the eastern United States (Shock, 2010; King and Stark, No Date). Potato 

yield can be reduced by both under- and over-irrigating (King and Stark, No Date). Potato processing 

can contribute to eutrophication of water (DEFRA, 2006). 

25
2.2.2 Soil Quality

Soil consists of solids (minerals and organic matter), liquids, and gases. This body of inorganic and 

organic matter is home to a wide variety of fungi, bacteria, and arthropods, as well as the growth 

medium for terrestrial plant life (USDA-NRCS, 2004). Soil is characterized by its layers that can be 

distinguished from the initial parent material due to additions, losses, transfers, and transformations of 

energy and matter (USDA-NRCS, 1999). It is further distinguished by its ability to support rooted plants 

in a natural environment. Soil plays a key role in determining the capacity of a site for biomass vigor and 

production in terms of physical support, air, water, temperature moderation, protection from toxins, 

and nutrient availability. Soils also determine a site’s susceptibility to erosion by wind and water, and 

flood attenuation capacity.

Soil properties change over time; temperature, pH, soluble salts, amount of organic matter, the carbonnitrogen ratio, numbers of microorganisms and soil fauna all vary seasonally, as well as over extended 

periods of time (USDA-NRCS, 1999). Soil texture and organic matter levels directly influence its shear 

strength, nutrient holding capacity, and permeability. Soil taxonomy was established to classify soils 

according to the relationship between soils and the factors responsible for their character (USDA-NRCS, 

1999). Soils are organized into four levels of classification, the highest being the soil order. Soils are 

differentiated based on characteristics such as particle size, texture, and color, and classified 

taxonomically into soil orders based on observable properties such as organic matter content and 

degree of soil profile development (USDA-NRCS, 2010). The Natural Resources Conservation Service 

(NRCS) maintains soil maps on a county level for the entire United States and its territories.

There are a multitude of organisms associated with soils, ranging from microorganisms to larger 

organisms, such as worms and insects. The microbial populations of the soil encompass an enormous 

diversity of bacteria, algae, fungi, protozoa, viruses, and actinomycetes (filamentous bacteria) (Doran et 

al., 1996).The extent of the diversity of microorganisms in soil is seen to be critical to the maintenance 

of soil health and quality. Microorganisms in soil are critical to the maintenance of soil function in both 

natural and managed agricultural soils because of their involvement in such key processes as soil 

structure formation; decomposition of organic matter; toxin removal; and the cycling of carbon, 

nitrogen, phosphorus, and sulfur (Bruinsma et al., 2003). In addition, certain microbial organisms may 

contribute to the protection of the root system against soil pathogens (Garbeva et al., 2004).

Potatoes grow well in a wide range of soils. Optimum soils are deep, loose, and drain well (Rosen, 

2010c). Poorly drained soils tend to yield poorly shaped tubers and tubers which are susceptible to 

diseases like tuber rot (Plissey and Erhardt, 2000; Johnson and Sideman, 2006). Sandy soils can also 

produce high-quality potatoes, but these soils are more susceptible to wind erosion (Rosen, 2010b). The

ability of soils to retain water is important because the drier soil becomes, the more difficult it is for the 

crop to pull water from it, and is dependent on soil texture and structure (DEFRA, 2006). Maintaining 

organic matter in soil is advisable because it keeps the soil loose and well-aerated, which in turn, leads 

to better penetration of root structures, and development of tubers, but is a problem in almost all 

regions where potatoes are grown except for those areas where soils contain muck and peat (Rosen, 

26
2010a). The recommended pH for soils is slightly acidic, which helps reduce incidence of diseases such as 

scab (Plissey and Erhardt, 2000; Johnson and Sideman, 2006).

Maintaining adequate soil conditions in potato fields may be difficult due to crop tillage, low crop 

residues on soil surfaces, and foot traffic from agricultural workers, which can lead to higher erosion 

rates. Erosion mitigation strategies include growing a cover crop and utilizing the subsequent crop plant 

residues (Hopkins et al., 2004). Where potatoes are grown in fields with stones such as in Maine, 

removal of stones may ease movement of mechanical harvesters, but may also negatively affect tuber 

yield (Saini and Grant, 1980). Soil compaction can occur with excessive tillage (Roberts and Cartwright, 

No Date), continuous cropping, and the use of large agricultural machines and increased pesticide 

spraying operations. As the number of machinery passes through the fields increases, soil compaction 

increases, and oxygen diffusion rate to roots decreases, which in turn may lead to a reduction in tuber 

size and increased soil erosion (Saini and Grant, 1980). Compacted soil also reduces the ability of roots 

to find water in soil (DEFRA, 2006).

2.2.3 Air Quality

The Clean Air Act (CAA) requires the maintenance of National Ambient Air Quality Standards (NAAQS). 

The NAAQS, developed by the EPA to protect public health, establish limits for six criteria pollutants: 

ozone (O3), nitrogen dioxide (NO2), carbon monoxide (CO), sulfur dioxide (SO2), lead (Pb), and inhalable 

particulates (coarse particulate matter [PM] greater than 2.5 micrometers and less than 10 micrometers 

in diameter [PM10] and fine particles less than 2.5 micrometers in diameter [PM2.5]). The CAA requires 

states to achieve and maintain the NAAQS within their jurisdiction. Each state may adopt requirements 

stricter than those of the national standard and each is also required by EPA to prepare a State 

Implementation Plan (SIP) containing strategies to achieve and maintain the national standard of air 

quality within the state. Areas that violate air quality standards are designated as non-attainment areas 

for the criteria pollutant(s), whereas areas that comply with air quality standards are designated as 

attainment areas. Non-attainment areas are typically associated with large metropolitan areas with 

many mobile (e.g., vehicle) and stationary (e.g., power plants and factories) sources. Other than 

emissions from mobile sources, crop farming emission sources are not specifically regulated nationwide 

under the CAA. The degree to which emissions from farming practices (such as prescribed burning) are 

allowed are location-specific within each State Implementation Plan (US-EPA, 2011e). Regulation of 

agricultural sources within a State Implementation Plan does not appear to be typical. For example, 

based on a review of the available plans in Idaho, achievement of air quality standards is focused on 

managing residential wood burning, vehicle emissions, and facilities such as factories and processing 

plants (US-EPA, 2011b).

Agricultural production may produce air emissions such as fugitive dust from the disturbance of bare soil 

from farming activities or wind, vehicle emissions, and emissions associated with fertilizer and pesticide 

applications. In some agricultural areas, prescribed burning is practiced and results in higher air 

emissions levels (US-EPA, 2011a). Ammonia may be lost to the atmosphere via inorganic nitrogenous 

fertilizers, but occurs mostly from livestock production processes such as manure storage and 

27
application. Atmospheric ammonia can then contribute to the eutrophication of surface water and 

acidification of soil and water (Zebarth et al., 1999)

The US EPA regulates mobile source emissions by reformulated gasoline and automobile pollution 

control devices (US-EPA, 2011a). Stricter requirements, such as vapor recovery nozzles on gas pumps, 

may apply in non-attainment areas.

2.2.4 Climate Change

Climate change represents a statistical change in global climate conditions, including shifts in the 

frequency of extreme weather. Agriculture is recognized as a direct (e.g., exhaust from equipment) and 

indirect (e.g., agricultural-related soil disturbance) source of greenhouse gas (GHG) emissions. The EPA 

has identified carbon dioxide (CO2), methane (CH4), and nitrous oxide (N2O) as the most important GHGs 

contributing to climate change. While each of these gases occurs naturally in the atmosphere, human 

activity has significantly increased the concentration of these gases since the beginning of the industrial 

revolution. The level of human produced gases accelerated even more so after the end of the Second 

World War, when industrial and consumer consumption expanded greatly. With the advent of the 

industrial age, there has been a 36% increase in the concentration of CO2, 148 % in CH4, and 18 % in N2O 

(US-EPA, 2012a)

Greenhouse gases vary in their global warming potential (GWP), and the US EPA converts all gases to 

carbon dioxide (CO2) equivalents. For the three greenhouse gases most associated with agriculture, 

GWPs are as follows: CO2 = 1, methane (CH4) = 21, and nitrous oxide (N2O) = 310 (US-EPA, 2012a). The 

US EPA classifies different sources by sector, with the energy sector being the largest contributor of 

greenhouse gas emissions (US-EPA, 2012a). The agriculture sector, as defined by US EPA, represented 

6.3 % of total greenhouse gas emissions for the United States in 2010 (US-EPA, 2012a). However, this 

does not include CO2 emissions and removals from agricultural-related land use activities such as liming 

of agricultural soils (which are included in the land use sector) and it does not include emissions of CO2

and N2O from diesel or gasoline-powered agricultural equipment (which are included in the energy 

sector). The primary greenhouse gases contributed by the agriculture sector as defined by US EPA are 

N2O and CH4. The relative percent contribution to total CO2 equivalent emissions of the various 

agricultural sources in 2010 was as follows: agricultural soil management (fertilizer application and 

other cropping practices that contribute N2O), 49 percent; enteric fermentation (primarily methane 

emissions from cattle), 33 percent; manure management, 16 percent; and rice cultivation, two percent. 

Most of the climate change potential from potato production is derived from transportation, packing 

and processing of potatoes. Emissions from field burning of agricultural residues, the remaining 

category, were less than 0.1 percent of the total (DEFRA, 2006; US-EPA, 2012a).

28
2.3 Biological Resources

This section provides a summary of the biological environment and includes an overview of animals, 

plants, microorganisms, and biodiversity associated with potato production. This summary provides the 

foundation to assess the potential impact to plant and animal communities.

2.3.1 Animal Communities

Animal communities in this discussion include wildlife species and their habitats. Wildlife refers to both 

native and introduced species of mammals, birds, amphibians, reptiles, invertebrates, and fish or 

shellfish. Agriculture dominates human uses of land (Robertson and Swinton, 2005). In 2011, 917 million 

acres (approximately 47%) of the contiguous 48 states were devoted to farming, including crop 

production, pasture, rangeland, and Conservation Reserve Program areas (USDA-NASS, 2012b). How 

these lands are maintained influences the function and integrity of ecosystems and the wildlife 

populations that they support. 

A wide array of wildlife species occur within the major potato-producing U.S. states and could possibly 

be found in potato fields at least intermittently. There are reports of wildlife feeding on foliage of 

potato, but reports of damage resulting in economic loss are uncommon. This is not surprising 

considering that the foliage and stems of potato contain toxic glycoalkaloids known to cause illness 

when consumed (Sinden, 1987). In 1992, APHIS Wildlife Services conducted formal appraisals of wildlife 

damage on 490 acres of potatoes in Wisconsin and did not report any damage or economic loss (USDAAPHIS, 2013c). However, white tailed deer have been reported to damage potatoes in some areas

(Marinette County, 2014) and it is well known that wild boar and voles will feed on tubers (O'Brien, 

2005; Taylor, 2014). USDA-APHIS Wildlife Services has also received complaints for damage caused by 

sandhill cranes (USDA-APHIS, 2013c).

There are numerous insects found in and around potato fields. Some insects and other invertebrates 

can be beneficial to potato production, providing services such as nutrient cycling and preying on plant 

pests. Many insects and invertebrates are detrimental to potato crops, including: Colorado potato 

beetle (Leptinotarsa decemlineata), various aphid species including the green peach aphid (Myzus 

persicae), wireworms (Limonius californicus, L. canus, Ctenicera pruinina), flea beetles (Epitrix sp.), 

European corn borer (Ostrinia nubilalis), potato psyllid (Bactericera (Paratrioza) cockerelli), tuberworm 

(Phthorimaea operculella), and the potato leafhopper (Emposasca fabae) (Johnson, 2007; Simplot, 

2013b). Nematodes can also be found in potatoes such as the root knot nematodes (Meloidogyne spp. 

), and cyst nematodes (Globodera pallida) and (G. rostochiensis) (Hardy, 1996). The potato crop is 

intensively managed with integrated pest management (IPM) practices to control these insects, 

nematodes, and several disease pathogens that include fungi, bacteria and viruses (Johnson, 2007) and 

to enhance potato yield. As a result, pesticides, including insecticides, nematicides, and fungicides, are 

generally part of an IPM strategy to keep losses below economic threshholds (US-EPA, 2000; Senseman, 

2007). Conventional broad-spectrum insecticides are potentially toxic to invertebrates and vertebrates. 

The US-EPA requires application control measures for certain Restricted Use insecticides to limit human 

29
and environmental exposure. These impacts can affect animal communities, with those communities 

within and in close proximity to potato fields experiencing the greatest impact (US-EPA, 2000; 2009b). 

2.3.2 Plant Communities

The landscape surrounding a potato field may be bordered by other potato fields, other crops, or may 

be surrounded by forest, grassland, bodies of water, or built-up areas. As discussed in Section 2.1, most 

commercial potatoes are grown in large agricultural areas, such as the Snake River Valley in Idaho. Thus, 

other crops would most frequently make up the surrounding vegetation, although some fields would be 

bordered by non-crop vegetation. Growers may provide buffer zones to reduce or prevent impact to 

adjacent vegetation. Because potatoes are grown throughout much of the United States, a wide variety 

of plants may be found adjacent to the agricultural fields. These plants have the potential to be 

impacted by agricultural practices, including the use of pesticides, which are regulated by US EPA. 

Aquatic plant communities near agricultural fields may be affected by sedimentation resulting from 

erosion, or by nutrients leached from fertilizers. 

Plants which compete with potato in crop fields are generally regarded as weeds, and are discussed in 

Section 2.1.2, General Agronomic Practices. Native or wild plant species related to cultivated potatoes 

are of interest because of the potential for interbreeding through gene flow. By definition, interbreeding 

between species that result in viable offspring is not common; otherwise the two plants would not be 

classified as different species. Interbreeding can occur to a limited extent between some species under 

some circumstances. Among the many factors that must be present for hybridization to occur between 

two species are: 1) the species must occur in the same area and habitat, 2) the flowering periods of the 

species involved must overlap, and 3) appropriate pollinators must be present (OECD, 1997). Section 

2.3.3, Gene Flow and Weediness discusses this subject.

Threatened and Endangered Species

There are currently three plants in the genus Solanum on the U.S. Fish and Wildlife Service (US FWS) list 

of threatened or endangered plant species: Erubia (S. drymophilum), found only in Puerto Rico; and 

popolo ku mai (S. incompletum) and Aiakeakua popolo (S. sandwicense), both found only in Hawaii 

(FWS, 2011) p. 47). Based on the evaluation of wild potatoes presented above, these species would not 

interbreed with cultivated potatoes; additionally, potatoes are not commercially grown in these areas.

2.3.3 Gene Flow and Weediness

Gene flow is a biological process that facilitates the production of hybrid plants, introgression of novel 

alleles (i.e., versions of a gene) into a population, and evolution of new plant genotypes. Gene flow to 

and from an agro-ecosystem can occur on both spatial and temporal scales. In general, plant pollen 

tends to represent the major reproductive method for transmission across geographic areas, while both 

seed and vegetative propagation tend to promote the movement of genes temporally and spatially.

30
The rate and success of gene flow is dependent on numerous external factors in addition to the 

donor/recipient plant. General external factors related to pollen-mediated gene flow include the 

presence/abundance/distance of sexually-compatible plant species; overlap of flowering phenology 

between populations; the method of pollination; the biology and amount of pollen produced; weather 

conditions, including temperature, wind, and humidity (Zapiola et al., 2008). Seed-mediated gene flow 

also depends on many factors, including the absence/presence/magnitude of seed dormancy; 

contribution and participation in various dispersal pathways, environmental conditions, and events.

Volunteer potatoes arise from overwintered tubers, and can be a weed problem in the following crop. 

Potatoes have a fairly low frost tolerance, and tubers planted too shallowly are subject to loss by frost. 

In temperate climates up to 20 % of tubers left in the soil show no dormancy and will sprout the next 

season (Andersson and de Vicente, 2010). However, volunteer potatoes can be easily controlled with 

cultivation and herbicides and do not persist as weeds for more than one or a few years (Andersson and 

de Vicente, 2010). In general, potato has a low propensity for weediness or persistence and is incapable 

of survival outside of agricultural production (Holm et al., 1979; Muenscher, 1980; Love, 1994; OECD, 

1997). 

Gene flow by hybridization is not possible for some potato cultivars such as the Russet Burbank, the 

most commonly grown potato, because they are reproductively sterile (PAA, 2009a; NSF, 2011; Simplot, 

2013b). Pollination of potato is mostly by bumblebees (Bombus impatiens), which have a relatively 

short flight range (less than three kilometers) (OECD, 1997). Pollen dispersal by nectar-seeking 

pollinators is limited because potato flowers are without any nectar. The honeybee (Apis mellifera) and 

Bombus fervidus are not attracted to them, and wind plays an insignificant role in pollination (OECD, 

1997). Empirical field testing of outcrossing distances in potato show that separations of 20 meters or 

more are sufficient to prevent outcrossing (Conner and Dale, 1996). Based on the relative lack of 

pollinator importance in potato production, APHIS does not further consider pollinator issues in this 

assessment. 

Of the fertile varieties, which include Ranger Russet, Atlantic and “G”, about 80 to 100 percent of true 

seed produced is derived from self-pollination (Hoopes and Plaisted, 1987). A potential source of 

volunteers is true potato seed (TPS). TPS is seed produced via pollination, which develops inside small 

fruiting bodies formed on the potato vine. Its major disadvantage is that it segregates for numerous 

traits because potato is highly heterozygous, and plants arising from TPS typically take longer to 

establish and set tubers, resulting in lower yield than from seed potatoes (Pallais, 1987; Simplot, 2013b).

Of the five parent varieties used to develop the 10 Simplot InnateTM potato events, Russet Burbank and 

“H” are fully sterile, precluding any possibility of TPS production. However, the Simplot InnateTM potato 

events derived from Ranger Russet, Atlantic and “G” are fertile and may produce TPS. But plants 

produced from TPS are no weedier than volunteer plants produced from over-wintered tubers and are 

relatively easy to control in rotational crops.

Potato (Solanum tuberosum) belongs to the Solanaceae plant family, along with other cultivated crop 

plants such as tomato (Solanum lycopersicon), eggplant (Solanum melogena), tobacco (Nicotiana 

31
tabacum), and pepper (Capsicum annuum) (OECD, 1997). S. tuberosum is divided into two subspecies: 

tuberosum and andigena. The subspecies Solanum andigena is also a cultivated species, but its 

cultivation is restricted to Central and South America (OECD, 1997). 

While there appears to be minimal, if any, overlap geographically between cultivated and wild potatoes 

in the United States, there is a possibility that a few wild potato plants may be growing near potato 

fields (Love, 1994). However, the potential for hybridization between wild and domesticated potatoes is 

extremely unlikely. Approximately 200 species of wild potatoes have been identified (Hijmans and 

Spooner, 2001), but only two species grow within U.S. borders, the tetraploid species Solanum fendleri

(recently reclassified as Solanum stoloniferum) and the diploid species Solanum jamesii (Bamberg et al., 

2003; Bamberg and del Rio, 2011). In addition to geographic separation (US-EPA, 2011c), there are 

several biological barriers to gene transfer such as multiple ploidy levels and endosperm imbalances 

(Love, 1994). Hybridization between native and cultivated potatoes has never been reported in the 

United States, although gene transfer has been accomplished using special laboratory techniques (Love, 

1994; US-EPA, 2011c).

2.3.4 Microorganisms

Soil microorganisms play a critical role in soil structure formation, decomposition of organic matter, 

toxin removal, nutrient cycling, most biochemical soil processes (Garbeva et al., 2004) and maintenance 

of soil structure and composition (Rosen, 2010b). Compared to soil supporting crops, fallow soil has the 

lowest microbial mass and diversity (Larkin, 2003). Microorganisms suppress soil-borne plant diseases 

and promote plant growth (Doran et al., 1996; Inceoglu et al., 2013). The main factors affecting 

microbial population size and diversity include soil type (texture, structure, organic matter, aggregate 

stability, pH, and nutrient content), plant type (providers of specific carbon and energy sources into the 

soil), and agricultural management practices (crop rotation, tillage, irrigation and herbicide and fertilizer 

application) (Garbeva et al., 2004; Rosen, 2010d). Crop type also may play an important role in the type 

of soil microorganisms in soils (Larkin, 2003). Plant roots, including those of potato, release a variety of 

compounds into the soil creating a unique environment for microorganisms in the rhizosphere, whereby 

microorganisms may be attracted to and stimulated by the roots (Inceoglu et al., 2013). Microbial 

diversity in the rhizosphere may be extensive and differs from the microbial community in the bulk soil 

(Garbeva et al., 2004).

Larkin (2006) investigated the effect of potato production on soil microbial communities over a period of 

three years. A two-year rotation period appears to control soil-borne disease. Potato soil microbial 

populations were lower than for several other crops, including canola, barley, and corn. Use of rotations 

also appeared to reduce the incidence and severity of black scurf, as well as reduced the number of 

misshapen tubers. Larkin (2006) suggested that activity and diversity of microbial populations were 

negatively correlated with the percentage of misshapen tubers.

In a study examining the abundance and structure of bacterial communities in a potato-barley-potato 

rotation, it was determined that the roots of all potato cultivars had positive effects on bacterial 

32
numbers in the soil, diversity and community structure of bacterial communities varied with time and 

season, and the composition of bacterial communities is linked to the specific requirements of different 

cultivars. Bacterial composition was potentially related to tuber starch content, as well as specific 

fertilizers (Inceoglu et al., 2013).

Pathogenic microorganisms which are associated with diseases of potatoes, is discussed in Section 2.1.2, 

General Agronomic Practices, Disease Control.

2.3.5 Biodiversity

Biodiversity refers to all plants, animals, and microorganisms interacting in an ecosystem. Biodiversity 

provides valuable genetic resources for crop improvement (Harlan, 1975; Wilson, 1988), and also 

provides other functions beyond food, fiber, fuel, and income. These include pollination, genetic 

introgression, biological control, nutrient recycling, competition against natural enemies, soil structure, 

soil and water conservation, disease suppression, control of local microclimate, control of local 

hydrological processes, and detoxification of noxious chemicals (Altieri, 1999). The loss of biodiversity 

results in a need for costly management practices in order to provide these functions to the crop (Altieri, 

1999). 

The degree of biodiversity in an agroecosystem depends on four primary characteristics: 1) diversity of 

vegetation within and around the agroecosystem; 2) permanence of various crops within the system; 3) 

intensity of management; 4) extent of isolation of the agroecosystem from natural vegetation

(Southwood and Way, 1970).

Agricultural land subject to intensive farming practices, such as that used in crop production, generally 

has low levels of biodiversity compared with adjacent natural areas (Altieri, 1999). Tillage, seed bed 

preparation, planting of a monoculture crop, pesticide use, fertilizer use, and harvesting limits the 

diversity of plants and animals (Lovett et al., 2003).

Biodiversity can be maintained or reintroduced into agroecosystems through the use of woodlots, 

fencerows, hedgerows, and wetlands. Agronomic practices include intercropping (the planting of two or 

more crops simultaneously to occupy the same field), agroforestry, crop rotations, cover crops, notillage, composting, green manuring (growing a crop specifically for the purpose of incorporating it into 

the soil in order to provide nutrients and organic matter), addition of organic matter (e.g., compost, 

green manure, animal manure), hedgerows and windbreaks (Altieri, 1999).

Because potatoes are grown throughout regions of the United States, there is a large diversity of plants 

and animals that inhabit the areas surrounding the potato fields. These include the weeds discussed in 

Section 2.1.2, Agronomic Practices, Weed Control, and animals in Section 2.3.1, Animal Communities.

33
2.4 Human and Animal Health

Humans are either consumers of potato and products derived from it, or are workers who produce 

potato crops. Under the FFDCA, it is the responsibility of food and feed manufacturers to ensure the 

products they market are safe and properly labeled. Food and feed derived from GE potato must be in 

compliance with all applicable legal and regulatory requirements. GE organisms used for food and feed 

may undergo a voluntary consultation process with the FDA prior to release onto the market. Although 

a voluntary process, thus far all applicants who wish to commercialize a GE variety that will be included 

in the food supply have completed a consultation with the FDA. In a consultation, a developer who 

intends to commercialize a bioengineered food meets with the agency to identify and discuss relevant 

safety, nutritional, or other regulatory issues regarding the bioengineered food and then submits to FDA 

a summary of its scientific and regulatory assessment of the food. FDA evaluates the submission and 

responds to the developer by letter. Simplot submitted a letter of consultation on February 12, 2013, 

which FDA is still reviewing (BNF No. 141).

As noted by the National Research Council (NRC), unexpected and unintended compositional changes 

arise with all forms of genetic modification, including both conventional hybridizing and genetic 

engineering (NRC, 2004). Genetic modification, as a source of uncertainty, is common to all forms of 

plant breeding. The NRC also noted that at the time, no adverse health effects attributed to genetic 

engineering had been documented in the human population. Reviews on the nutritional quality of GE 

foods generally conclude that there are no significant nutritional differences in conventional versus GE 

plants for food or animal feed (Faust, 2002; Flachowsky et al., 2005).

2.4.1 Consumer Health

The potato is the world’s number one non-grain food commodity (FAO, 2008). Potatoes are high in 

nutrients and at least twelve essential vitamins, especially vitamins B and C, and minerals such as iron, 

potassium, and zinc (Arvanitoyannis et al., 2008; FAO, 2008; Bushway, 2010). They have the highest 

protein content (around 2.1 percent on a fresh weight basis) in the family of root and tuber crops. As a 

low-fat source of carbohydrates, potatoes can be instrumental in providing a solution to long-term 

problems of world hunger (Bushway, 2010).

Because of their high sugar and starch content and resulting high glycemic index, consumption of 

potatoes by persons with diabetes or similar conditions may need to eat potatoes sparingly. 

U.S. per capita potato consumption is summarized in Table 6. 

Table 6. U.S. Per Capita Potato Consumption 2011

Fresh Processing All 

34
Market

Canned Frozen Chips Dehydrated

Total 

Processing

Potatoes

2011p 34 1 48 17 11 76 110

Source: (NPC, 2012). Units are in lbs./person/year. Individual components may not add up to the total due to rounding and 

2011 values are preliminary.

Toxins and Allergens in Potato

Potatoes contain two classes of toxins and/or allergens: glycoalkaloids and patatins. Acrylamide is a 

toxic compound formed in cooking potatoes at high temperatures, such as baking and frying.

Glycoalkaloids are well-known, naturally-occurring compounds that are present in all potatoes that likely 

serve as a defense mechanism against predator attack. These compounds are concentrated in foliage, 

flowers and sprouts, although glycoalkaloids are present in lower concentrations in other parts of the 

plant, including tubers. For food safety purposes, an upper limit for glycoalkaloid content of 20 

milligrams per 100 grams of potato is generally accepted. Concentrations exceeding this level are 

potentially poisonous to humans and livestock. Harvested tubers exposed to light (Sinden, 1987). 

Concentrations exceeding this are potentially poisonous to humans and livestock. Light exposure to 

harvested tubers can increase glycoalkaloid content in potatoes, and may result in green areas of 

coloration on potato skins (Sinden, 1987; IPC, 2010).

Patatins are a family of proteins comprising 30 to 40 percent of the soluble protein in potatoes (Mignery

et al., 1988). Allergic reactions to cooked potatoes are considered to be very uncommon and were 

reported only in children (De Swert et al., 2002). Patatin was identified as the major allergen involved in 

this reaction (De Swert et al., 2007). Individuals who are allergic to patatin would need to avoid eating 

potatoes because potato protein naturally contains a relatively large proportion of patatin.

Of greatest significance to human health is the toxic compound acrylamide, which is a known carcinogen 

of rodents and a probable human carcinogen (WHO-IARC, 1994; NTP, 2011; Chawla et al., 2012; Halford

et al., 2012a). In particular, risk of endometrial and ovarian cancer appears to increase with increased 

acrylamide intake (Pedreschi, 2009). Acrylamide is also regarded as a mammalian cell mutagen, wherein 

very low dosages of the compound can damage chromosomes (Chawla et al., 2012). Acrylamide has 

also been reported to be a cumulative neurotoxin (Friedman, 2003).

Acrylamide is formed in potatoes which are cooked at high temperatures, such as baking or frying. In 

2002, Swedish researchers demonstrated that acrylamide forms when starchy foods, such as potatoes 

and breads, are heated at high temperatures, but not in unheated or boiled foods (Tareke et al., 2002; 

Halford et al., 2012a). Therefore, even though dietary exposure to acrylamide is measurable, it is not a 

natural compositional component of unheated foods derived from plants. Acrylamide forms during the 

Maillard reaction (Martins et al., 2000) which is a reaction at high temperatures (such as frying French 

35
fries) between certain sugars such as glucose and fructose (reducing sugars) and asparagine (an amino 

acid) that are naturally present in the food (FDA, 2009). In addition, prolonged heating time increases 

acrylamide content, whereas higher moisture content reduces acrylamide content (Kotsiou et al., 2013).

Maillard reaction products, which affect the flavor and texture of the cooked food, are formed by a 

chemical reaction between an amino acid and a reducing sugar (Halford et al., 2012b). Oxidation of the 

free amino acid asparagine, a major amino acid in potatoes and cereals (Mottram et al., 2002; Chawla et 

al., 2012), is the main source of acrylamide when starchy foods are baked or fried (Stadler et al., 2002; 

Friedman, 2003; Halford et al., 2012a; Kotsiou et al., 2013). Color of cooked potato products such as 

potato chips has been found to correlate well with acrylamide formation: the darker the color, the 

higher the greater the acrylamide concentration (Arvanitoyannis et al., 2008; Pedreschi, 2009; Halford et 

al., 2012a; Kotsiou et al., 2013).

Important variables leading to acrylamide formation and affecting acrylamide concentration in cooked 

potatoes include reducing sugar content, processing/cooking temperature and method, 

cooking/processing time, moisture content, and additives (Halford et al., 2012a; Kotsiou et al., 2013). In 

turn, concentrations of sugars and amino acids are influenced by cultivar, fertilizers, climate, and 

storage conditions (Pedreschi, 2009). 

It is estimated that potato chips and fried potato products such as French fries are responsible for about 

1/3 of the human dietary exposure to acrylamide (Chawla et al., 2012). Acrylamide is also present in 

other foods such as coffee, some breads, biscuits, gingerbread, and processed onion mix and dip mixes. 

Smoking may contribute to human exposure to acrylamide (Friedman, 2003; Chawla et al., 2012; Kotsiou

et al., 2013). 

For all of these reasons, the discovery of acrylamide in cooked potato products has raised concerns 

throughout the potato processing industry, as well as among consumers. The FAO/WHO Expert 

Committee on Food Additives has recommended that dietary exposure to acrylamide should be reduced

(FAO/WHO, 2011). Perhaps because children consume more acrylamide-laden products such as French 

fries and potato chips, their exposure to the chemical is greater than for adults (Friedman, 2003; Halford

et al., 2012b). The State of California listed acrylamide as a potential carcinogen under Proposition 65 in 

1990 and established a No Significant Risk Level (NSRL) of 0.2 μg/day (CEPA-OEHHA, 2005). Subsequent 

to the discovery of acrylamide in cooked foods, this NSRL was revised to 1.0 μg/day (CEPA-OEHHA, 

2005). FDA has recently released draft guidance for the food industry to reduce acrylamide in foods

(FDA, 2013a).

Proposition 65 requires that food manufacturers warn consumers about the dangers of acrylamide in 

their products. In 2005, the State of California sued Frito-Lay, Kettle Foods and Lance, Inc. for failing to 

provide such warnings. In the settlement, the potato chip manufacturers agreed to reduce the 

acrylamide in their products to 275 ppb, low enough to avoid the Proposition 65 warning. These three 

companies also agreed to pay close to $2M in penalties and court costs. The potato processing industry 

now has a strong financial incentive to reduce the levels of acrylamide in their retail products.

36
2.4.2 Worker Health

Worker hazards in farming are common to all types of agricultural production, and include hazards from

equipment and plant materials. Pesticide application represents the primary exposure route to 

pesticides for farm workers. Workers engaged in potato production may encounter insecticides, 

herbicides, fungicides or fertilizers that may pose a worker health or safety risk, unless used in 

accordance with the US-EPA established agriculture-specific requirements in the Worker Protection 

Standard (WPS) (40 CFR Part 170) that protect workers from the hazards of chemical exposure. The WPS 

offers protections to more than two and a half million agricultural workers who work with pesticides at 

more than 560,000 workplaces on farms, forests, nurseries, and greenhouses. The WPS contains 

requirements for pesticide safety training, notification of pesticide applications, use of personal 

protective equipment, restricted entry intervals following pesticide application, decontamination 

supplies, and emergency medical assistance. The Occupational Safety and Health Administration require

all employers to protect their employees from hazards associated with agricultural chemicals. The EPA 

pesticide registration process, however, involves the design of use restrictions that if followed have 

been determined to be protective of worker health.

A potato field is a highly managed environment which incorporates the use of agricultural chemicals, 

including herbicides and insecticides. Pesticides are used on most potato acreage in the U.S., and 

changes in acreage, crops, or farming practices can affect the amounts and types of pesticides used and 

thus the risks to workers. Worker safety precautions and use restrictions are noted clearly on pesticide 

registration labels. Growers are required to use pesticides consistent with the application instructions 

provided on the EPA-approved pesticide labels. These restrictions provide instructions as to the 

appropriate levels of personal protection required for agricultural workers. These may include 

instructions on personal protective equipment, specific handling requirements, and field reentry 

procedures (see, e.g. (Carroll and Robinson, 2006)).

2.4.3 Animal Feed

Potatoes used as livestock feed accounted for approximately 1 % of all potatoes produced in the United 

States in 2012 (see Table 7). This quantity includes potatoes sold specifically as livestock feed and 

potatoes used as livestock feed on farms where the crop was grown. It does not include the potato 

waste that was used for livestock feed (USDA-NASS, 2013a). Use of potatoes for livestock feed is 

generally dependent on quality and price: for example, when potatoes are low in both price and quality, 

more of the crop tends to be used for livestock feed. Prices for feed are usually the lowest of all potato 

usage categories (Guenther, 2010c).

37
Table 7. U.S. 2012 Potato Utilization

Utilization Item CWT (1,000) (% of potatoes 

harvested) 

Sales – fresh and processing 

Table stock (fresh) 118,535 (25.6%)

Processing

 Chips and shoestrings 56,349 (12.2%)

 Dehydrated (except starch and flour) 50,559 (10.9%)

 Frozen French fries 144,910 (31.3%)

 Other frozen products 20,912 (4.5%)

 Canned products 1,764 (0.4%)

 Other canned products (hash, stews, soup) 695 (0.2%)

 Starch, flour and other 8,031 (1.7%)

 Total processing 282,220 (61.0%)

Other sales

Livestock feed 4,080 (0.9%)

Seed 23,706 (5.1%)

Non-sale

Seed used on farms where grown 3,286 (0.7%)

Household and feed use on farms where grown 1,583 (0.3%)

38
Utilization Item CWT (1,000) (% of potatoes 

harvested) 

Shrinkage and loss 28,356 (6.1%)

Total Production 462,766

Source: (USDA-NASS, 2013a)

Potatoes constitute at least part of the diet for several domestic animals, including cattle, horses, pigs, 

and poultry. The recommended rate of feed is approximately 25-40 lb. potatoes/1,000 lb. live weight, 

but can vary with the type of animal. Potatoes are considered to be a palatable feed, and are high in 

moisture content, but are not as nutritious as grain or corn silage (e.g., it takes 400-500 lbs. of potatoes 

to provide the same nutritive value as 100 lbs. of grain (Corbett, No Date).

Feed does not include the leafy green foliage of potato plants since flowers, sprouts, and foliage has

abundant glycoalkaloids, which are potentially poisonous for livestock (Sinden, 1987).

Similar to the regulatory control for direct human consumption of potato under the FFDCA, it is the 

responsibility of feed manufacturers to ensure that the products they market are safe and properly 

labeled. Feed derived from GE potato must comply with all applicable legal and regulatory 

requirements, which in turn protects human health. To help ensure compliance, GE organisms used for 

feed may undergo a voluntary consultation process with FDA before release onto the market, which 

provides the applicant with any needed direction regarding the need for additional data or analysis, and 

allows for interagency discussions regarding possible issues. Consequently, any uncertainty in this area is 

addressed during an FDA inquiry process. 

Although a voluntary process, thus far all applicants who wish to commercialize a GE variety that 

will be included in the food supply have completed a consultation with the FDA. In a consultation, 

a developer who intends to commercialize a bioengineered food meets with the agency to identify 

and discuss relevant safety, nutritional, or other regulatory issues regarding the bioengineered food 

and then submits to FDA a summary of its scientific and regulatory assessment of the food. FDA 

evaluates the submission and responds to the developer by letter. Simplot submitted a letter to 

FDA on February 12, 2013, which FDA is currently reviewing (BNF No. 141).

2.5 Socioeconomics

As part of an evaluation of impacts on the human environment, NEPA requires consideration of 

economic and social effects (40 CFR 1508.8), whether direct, indirect, or cumulative. However, under 

39
CEQ regulations (40 CFR 1508.14), “. . . economic or social effects are not intended by themselves to 

require preparation of an environmental impact statement.”

The following socioeconomic factors are considered in this EA: the interaction of social and economic 

factors that affect agricultural production and products, including farm income and employment, crop 

production expenses, crop value and trade.

2.5.1 Domestic Economic Environment

Potatoes contribute approximately 15 % of farm sales receipts for vegetables, making potatoes the 

leading vegetable crop in the United States (USDA-ERS, 2012b). The total value of U.S. potato 

production in 2012 was $3.9 billion, the average yield was 409 CWT/acre and the average price received 

was $7.26/cwt (USDA-NASS, 2012c). Unlike true commodity crops such as corn and soybeans, most 

potatoes are grown for a specific market. As shown in Table 8, the Russet Burbank and Ranger Russet 

are primarily used for fries, and the Atlantic, “H”, and “G” varieties are primarily used for chips. Atlantic 

is the standard for making potato chips from the field or from very short storage (PAA, 2009b). Any of 

these varieties can also be sold on the fresh market. On the fresh market, Russet Burbank and Ranger 

Russet potatoes are the standard for baking (Pavek et al., 1992; PAA, 2009a). Other varieties are used 

for canning and are well-suited for boiling. There are thousands of potato varieties, some intended for 

very small markets (FAO, 2008).

Uses for all potato varieties combined in the United States are summarized in Table 8. Specific varieties 

are not grown for the dehydration market or for livestock feed; rather, food-grade potatoes considered 

unsuitable for their intended fresh or other processing markets are usually used for these purposes 

(Guenther, 2010c). Because potato sales for livestock feed usually receive the lowest price, potatoes are 

not sold for livestock feed if other uses are available (Guenther, 2010c).

Table 8. A Sample of U.S. Potato Varieties and their Uses

Variety1 Use

Russet Burbank Boiling, baking, chipping, French frying

Ranger Russet Baking, French frying

Atlantic Fresh market, chipping

Kennebec Boiling, pan frying, chipping, French frying

Norland Boiling, French frying, chipping

40
Yukon Gold Fresh market, boiling, baking, French frying

1 http://potatoes.wsu.edu/varieties/vars-all.htm

Fresh market potatoes in North America can be classified broadly as russets, reds, yellows or whites 

based on skin color. Most eastern potato growers also are involved in packing; in the west, the 

businesses are usually separate. Recently, western growers have entered the packing business, often in 

partnerships or cooperatives with other growers (Guenther, 2010a). 

Fresh potatoes may be shipped in refrigerated rail cars or trucks to maintain a high standard of quality 

whereas frozen and dehydration processing typically occurs near potato production areas. The fragility 

of chips and the high cost of shipping low-density products results in most chipping plants being located 

near populated areas. Except for dehydrators, processors typically contract for most of their needs and 

buy the remainder on the open market. Some dehydrators segregate potatoes that are suitable for the 

fresh market, and then sell those on the fresh market, processing the rest. Others purchase off-grade 

potatoes from fresh packers for processing (Guenther, 2010b).

Revenues and costs of potato production vary widely, depending on geography, growing conditions, the 

local economy, the type of potato, farm size, and other factors. For example, the 2011 per acre 

operating cost of growing Russet Burbank potatoes in southwestern Idaho, including on-farm storage 

and fumigation, was $2,811 (Patterson, 2011). In the same year, the gross return per acre averaged 

$4,107.50, resulting in a net return of $1,297. When that same variety was grown in south-central 

Idaho, the 2011 per acre operating cost, including on-farm storage and fumigation, was $2,560 

(Patterson, 2011), and the gross return per acre averaged $3681.25, resulting in a net return of $1,121.

Approximately 90 percent of U.S. potatoes are planted in the spring and harvested in the fall, and 

western states produce two-thirds of the fall potatoes. The storage abilities of potatoes enable fallseason potato varieties to be sold in fresh or processing markets throughout the September-August 

marketing year. Less than 10 percent of potatoes are harvested in winter, spring and summer; however, 

these potatoes meet specific market needs (e.g., new potatoes) and tend to yield higher prices than fall 

potatoes (USDA-ERS, 2012b).

Sale values per acre are normally highest for the winter crop and lowest for fall potatoes, but varies 

widely among the producing states. Prices for fresh potatoes are usually higher than prices for 

processing potatoes due to crop-quality standards. Domestic potato prices may vary not only in 

response to changes in weather, yield or demand, but also to changes in supply from imported potatoes 

and potato products. If a large quantity of frozen French fries enters the country, U.S. potato processors 

may cut back on contracts for processing potatoes, which would be diverted to the fresh market. Fresh 

market prices would likely fall as a result (USDA-ERS, 2012b).

41
Not all potatoes are sold for food. The largest non-sales category is “shrinkage and loss”, which 

accounts for the water weight loss and loss due to respiration during storage. Also in this category are 

potatoes that do not meet market quality standards due to decay, bruising, greening, sprouting and 

disease. Crops that suffer frost damage also are added to this category (Guenther, 2010c). 

Potato production requires numerous expenditures, including for specialized machinery. The largest 

conventional operating cost items are fertilizer, chemicals and pesticides, storage and seed potatoes. 

Fertilizer and seed accounted for 25 percent of total production costs in eastern Idaho in 2007 

(Patterson, 2010). Potato production costs for irrigation in the western United States ranges between 

$1,500 and $3,500 per acre (Patterson, 2010). Costs do not stop accumulating at harvest unless the 

potatoes are sold out of the field. Additional costs are incurred to store potatoes.

For those producing organic potatoes, an organic production system is required in addition to a 

relatively long crop rotation to minimize pest problems. Profitability margins differ between organic 

farm sizes, but a study conducted in southern Idaho indicated that net returns over variable costs for a 

small farm (30-50 acres) with 100% organic premiums is $1,026/acre and $1,148/acre for a large farm 

(100-120 acres) (Painter et al., 2010). Smaller farms have higher operating costs as a result of smaller, 

less efficient machinery, and their machine hours for potato production are more than double the hours 

on a large organic farm. While larger farms reduce labor expenses by half with more efficient 

machinery, they do have an increase in capital costs. Organic potato growers face challenges, including 

growing sufficient fall cover crops to supply soils with additional nitrogen, but profit margins for organic 

potatoes have the potential to exceed those for conventional potatoes if these and other challenges are 

addressed (Painter et al., 2010).

In general, post-harvest losses are a significant part of the production costs of fruits and vegetables, and 

may reach as high as 50% (Martinez and Whitaker, 1995; Llorente et al., 2011). Browning of fruits and 

vegetables negatively affects consumer acceptance because of altered appearance and perceived 

nutritional deficit (Llorente et al., 2011). Specifically, potato growers can lose up to 20% of income 

through potato injury at harvest (Preston, 2010). The potato industry, therefore, has a vested interest 

in minimizing these losses. 

Black spot bruise is typically caused by mechanical injury to tubers during harvest, handling, storage, or 

processing such as scuffing and cracking of the skin (Dirks-Hofmeister et al., 2013). Injury leads to a 

bluish-grey to black discoloration of internal tuber tissue (Stremmel et al., 2010). Bruising symptoms do 

not appear until 3 hours to 24 hours following mechanical impact, and are not visible until the skin is 

removed from the tuber (Stremmel et al., 2010; Urbany et al., 2011). Because bruising cannot be 

observed until the potato skin is removed, it is more difficult to identify damaged tubers, and makes 

conventional means of breeding to eliminate this trait more problematic (Urbany et al., 2012).

Physical tuber properties, such as tissue stiffness and elasticity, affect transfer of the impact energy to 

the tuber and may affect susceptibility of the tuber to bruising. For example, if potato tissue does not 

crack during injury, the force of the impact is more evenly distributed throughout a larger area of the 

42
tuber, which results in greater changes to metabolism, and, hence more bruising (Stremmel et al., 

2010). Therefore, bruising susceptibility varies widely among potato cultivars (Stremmel et al., 2010). To 

a large extent, susceptibility is dependent on multiple genetic traits, as well as on maturity of tubers and 

environmental factors (Urbany et al., 2011). Potato genotypes with high tuber starch content are more 

susceptible to bruising (Urbany et al., 2012).

The chemical basis for black spot bruising lies in the cellular release of phenolic compounds, normally 

compartmentalized in the vacuoles, following injury (Tran et al., 2012). The phenolic compounds are 

converted to o-phenols and o-quinones by the enzyme polyphenol oxidase (PPO) (Dirks-Hofmeister et 

al., 2013). These quinoids auto-oxidize, forming melanin, leading to blackened tissue which is called 

enzymatic browning and is undesirable in processed potato product (Hunt et al., 1993; Steffens, 1994; 

Stremmel et al., 2010; Llorente et al., 2011; Vitti et al., 2011). Oxidative browning reactions generally 

cause deterioration in food quality by changing nutritional and organoleptic properties, and can involve 

changes in texture and flavor as well as color (Yoruk and Marshall, 2003). The side chains of essential 

amino acids in plant proteins may interact with quinones, leading to a reduction in nutritional quality

(Yoruk and Marshall, 2003). Degree of discoloration is strongly related to PPO activity (Urbany et al., 

2011). Polyphenol oxidase expression is mediated by a multi-gene family in potato (Thygesen et al., 

1995; Llorente et al., 2011).

Storage temperatures also affect the likelihood of black spot bruise (Preston, 2010) since increased 

temperature heightens PPO activity (Yoruk and Marshall, 2003; Vitti et al., 2011). 

2.5.2 Trade Economic Environment

U.S. and global trade are greatly affected by the growth and stability of world markets, including 

changes in world population, economic growth, and income. Other factors affecting agricultural trade 

are global supplies and prices, changes in exchange rates, government support for agriculture, and trade 

protection policies. 

U.S. farmers and agricultural firms rely heavily on export markets to sustain prices and revenues 

because productivity of U.S. agriculture increases faster than the demand for domestic food and fiber. 

U.S. food imports have increased with the corresponding increase in demand for greater diversity in the 

food supply. U.S. consumers benefit from imports because imports expand food variety. This also tends

to stabilize year-round supplies of and prices for fresh fruits and vegetables.

U.S. exports of potatoes and potato products have grown 133 % in value and 79 % in volume during the 

last 10 marketing years (Board, 2013). Frozen potato products comprise 60 % of the U.S. potato 

exports. During the 2012/ 2013 market year (September-August), U.S exports of potatoes and potato 

products totaled $1.6 billion—up from $1.4 billion in the previous market year (USDA-ERS, 2013). 

Exports to target markets were led by an increase in shipments to Mexico, South Korea, Malaysia, and 

Vietnam. During the 2012/ 2013 market year, Canada was the largest market for chips while Japan was 

the largest market for frozen potato products and dried, flour, and meal potato products (Board, 2012; 

43
USDA-ERS, 2013). Mexico provides the United States with the largest market for exporting potato flakes 

and granules and is the second largest market destination for frozen potatoes (Board, 2012; USDA-ERS, 

2013)

U.S. potato and potato product exports are expected to grow during the upcoming marketing year 

(Board, 2013). Growth rates will depend upon economic growth in the markets and the supply and price 

of competitor products. The United States will facilitate the growth of the export market by continuing 

to gain new market access, as just occurred for fresh table-stock to the Philippines (Board, 2013).

2.5.3 Organically Certified Economic Environment

In the United States, products produced using only specific methods and certified under the USDA AMS 

National Organic Program (NOP) definition of organic farming can be marketed and labeled as “organic” 

(USDA-AMS, 2010). Organic certification is a process-based certification; not a certification of the end 

product. The certification process specifies and audits the methods and procedures by which the 

product is produced.

In accordance with NOP, each year an accredited organic certifying agent must review an operation. 

This must include a review of its organic system plan and record-keeping practices, and an on-site 

inspection of the production area(s). Organic growers must maintain records to show that production 

and handling procedures comply with USDA organic standards.

Section 205.105 of the regulations identifies “Allowed and prohibited substances, methods, and 

ingredients in organic production and handling.

“To be sold or labeled as ‘100 percent organic,’ ‘organic,’ or ‘made with organic’ (specified ingredients or 

food group(s)),” the product must be produced and handled without the use of: . . . (e) Excluded 

methods . . . .”

Excluded methods identified at 7 CFR Section 205.2, are defined as follows:

“A variety of methods used to genetically modify organisms or influence their 

growth and development by means that are not possible under natural 

conditions or processes and are not considered compatible with organic 

production. Such methods include cell fusion, microencapsulation and 

macroencapsulation, and recombinant DNA technology (including gene 

deletion, gene doubling, introducing a foreign gene, and changing the positions 

of genes when achieved by recombinant DNA technology). Such methods do not 

include the use of traditional breeding, conjugation, fermentation, 

hybridization, in vitro fertilization, or tissue culture.”

Organic farming operations, as described by the NOP, are required to have distinct, defined boundaries 

and buffer zones to prevent unintended contact with excluded methods from adjoining land that is not 

under organic management. Organic production operations must also develop and maintain an organic 

44
production system plan approved by their accredited certifying agent. This plan enables the production 

operation to achieve and document compliance with the National Organic Standards, including the 

prohibition on the use of excluded methods (USDA-AMS, 2010).

Common practices organic growers may use to exclude GE products include planting only organic seed, 

planting earlier or later than neighboring farmers who may be using GE crops, so that the crops will 

flower at different times, and employing adequate isolation distances between organic and neighboring 

fields to minimize the chance for pollen exchange between fields (NCAT, 2003). Although the national 

organic standards prohibit the use of excluded methods, they do not require testing of inputs or 

products for the presence of excluded methods. The presence of a detectable residue of a product of 

excluded methods alone does not necessarily constitute a violation of the national organic standards 

(USDA-AMS, 2010). The current NOP regulations do not specify an acceptable threshold level for the 

adventitious presence of GE materials in an organic-labeled product. The unintentional presence of the 

products of excluded methods will not affect the status of an organic product or operation if excluded 

methods were used and reasonable practices were implemented to avoid contact with products of 

excluded methods as detailed in their approved organic system plan (Ronald and Fouche, 2006; USDAAMS, 2010).

Organic market and products

The organic sector is rapidly growing both in the United States and the EU. Consumer purchases in 

these two regions made up 95 % of estimated world retail sales of organic food products in 2003 (Dimitri 

and Oberholtzer, 2009). Annual manufacturer survey results (Organic Trade Association, 2011), 

indicated that estimated U.S. organic food sales for 2010 were $26.7 billion. This represented a 7.7 %

growth rate from the previous year. The market sector experiencing the highest growth rate during 

2010 was organic fruits and vegetables, which increased 11.8 % compared with 2009 sales. The market 

share for organic fruits and vegetables was 11 % of all U.S. fruit and vegetable sales (Organic Trade 

Association, 2011). Organic products represented approximately 4% of total 2010 sales in the food and 

beverage sector (Organic Trade Association, 2011). 

Organic Potatoes

In 2008, 2.2 million cwt of organic potatoes were harvested, with a total sales value of almost $29

million ($13.24/cwt) (USDA-NASS, 2012a). Prices for organic potatoes are typically substantially higher 

than the overall average conventional potato price, and probably reflect both the organic premium and 

the fact that most organic potatoes are sold fresh. Organic growers typically receive a significant price 

premium when they can sell their potatoes as organic (Dufour et al., 2009); however, that market is not 

always available (Esplin, 2009). The organic potato market is not highly structured (Dufour et al., 2009). 

At least one manufacturer produces organic potato chips (Foods, 2009).

45
3. ALTERNATIVES

This document analyzes the potential environmental consequences of a determination of 

nonregulated status of Simplot InnateTM potato. 

Two alternatives are evaluated in this EA: (1) no action and (2) determination of nonregulated status of 

event. APHIS has assessed the potential for environmental impacts for each alternative in the 

Environmental Consequences section.

3.1 No Action Alternative: Continuation as a Regulated Article

Under the No Action Alternative, APHIS would deny the petition. Simplot InnateTM potato and progeny 

derived from Simplot InnateTM potato would continue to be regulated articles under the regulations at 7 

CFR part 340. Permits issued or notifications acknowledged by APHIS would still be required for 

introductions of Simplot InnateTM potato and measures to ensure physical and reproductive confinement 

would continue to be implemented. APHIS chooses this alternative when there is a clear pest risk, or if 

there is insufficient evidence to demonstrate the lack of plant pest risk from the unconfined cultivation 

of Simplot InnateTM potato. This alternative is not the Preferred Alternative because a Plant Pest Risk 

Assessment (PPRA) found Simplot InnateTM potato is unlikely to pose a plant pest risk (USDA-APHIS, 

2013a). 

3.2 Preferred Alternative: Determination That Simplot InnateTM Potato Is No Longer a Regulated 

Article

Under this alternative, Simplot InnateTM potato and derived progeny would no longer be regulated 

articles under the regulations at 7 CFR part 340. Permits issued or notifications acknowledged by APHIS 

would no longer be required for introductions of Simplot InnateTM potato and progeny derived from this 

event. Under this alternative, growers may have future access to Simplot InnateTM potato and progeny 

derived from this event if the developer decides to commercialize Simplot InnateTM potato.

This alternative meets the purpose and need to respond appropriately to a petition for nonregulated 

status when there is a determination of no pest risk. Based on the PPRA conclusion that Simplot InnateTM

potato is unlikely to pose a plant pest risk (USDA-APHIS, 2013a), conferring nonregulated status to 

Simplot InnateTM potato is a response that is consistent with the plant pest provisions of the Plant 

Protection Act, the regulations codified in 7 CFR part 340, and the biotechnology regulatory policies in 

the Coordinated Framework.

3.3 Alternatives Considered But Rejected from Further Consideration

APHIS assembled a list of alternatives that might be considered for Simplot InnateTM potato. The agency 

evaluated these alternatives, in light of the agency's authority, environmental safety, efficacy, 

practicality, and other concerns. APHIS rejected several alternatives based on the discussions 

summarized in this section. 

46
3.3.1 Prohibit Any Simplot InnateTM Potato from Being Released

In response to public comments stating a preference for GE organisms to not enter the marketplace, 

APHIS considered prohibiting the release of Simplot InnateTM potato, including denying any permits 

associated with the field testing. APHIS determined this alternative is not a reasonable alternative 

because APHIS found Simplot InnateTM potato is unlikely to pose a plant pest risk (USDA-APHIS, 2013a).

This finding is consistent with the PPA and EO 13563. Based on the findings and scientific data 

evaluated in the PPRA (USDA-APHIS, 2013a), use of this potato is not expected to change the risk of 

gene flow or weediness in comparison to other potato cultivars. It is not expected to change the range, 

area, and agronomic practices used in potato production (machine use and fertilizer application). 

Therefore, there is no basis in science for finding a plant pest risk, and consequently prohibiting the 

release of Simplot InnateTM potato.

3.3.2 Approve the Petition in Part

The regulations at 7 CFR 340.6(d) (3) (i) state that APHIS may "approve the petition in whole or in part." 

In this alternative, APHIS considered partial deregulation where progeny would not be deregulated. 

Restrictions prohibiting future “gene stacking” are unlikely to reduce plant pest risks because these 

genes are not associated with pest risk (USDA APHIS, 2013a), and may lead to a human health benefit. 

As an alternative, this choice would merely delay agency decision making, and could be perceived as 

creating an unnecessary competitive restraint in the economy. For these reasons, partial approval is not 

a reasonable alternative.

3.3.3 Isolation Distance between Simplot InnateTM Potato and Non-GE Potato Production 

and Geographical Restrictions

In response to public concerns of gene movement between GE and non-GE plants, APHIS considered 

requiring an isolation distance separating Simplot InnateTM potato from conventional or specialty potato

production. Isolation distances may be useful when wind-borne pollen is likely to disseminate genes 

long distances. Potato is not considered to be a wind-pollinated crop (OECD, 1997b), so imposing an 

ineffective restriction makes this alternative unreasonable. Further, an alternative based on requiring 

isolation distances would be inconsistent with the finding that Simplot InnateTM potato is unlikely to pose 

a plant pest risk (USDA-APHIS, 2013a). 

APHIS also considered geographically restricting the production of Simplot InnateTM potato. The 

restrictions could be based either on the production locations of non-GE potato in organic production 

systems, or production systems for GE-sensitive markets, or in response to public concerns regarding 

possible gene movement between GE and non-GE plants. The PPRA did not identify geographic 

differences associated with any identifiable plant pest risks for Simplot InnateTM potato (USDA-APHIS, 

2013a) and found it will not exhibit a greater plant pest risk in any geographically restricted area. To 

restrict production locations when there is unlikely to be any productive value creates an ineffective 

47
restriction that makes this alternative unreasonable. Further, an alternative based on restrictions to 

production locations would be inconsistent with the finding that Simplot InnateTM potato is unlikely to 

pose a plant pest risk (USDA-APHIS, 2013a).

Based on the foregoing, individual farmers may choose to geographically isolate their non-GE potato

production systems from potato, or use isolation distances and other management practices to 

minimize gene movement among potato fields. This stance correctly places these burdens on those 

wishing to enter a specialty or niche market, rather than placing unsupportable regulatory controls on a 

plant variety that is unlikely to pose a plant pest risk. The likelihood of market penetration by plants 

with these genes is not a proper regulatory concern under APHIS authority. Whether these genes 

become incorporated into other varieties depends on market forces that APHIS cannot predict and are 

irrelevant to the APHIS finding of no pest risk. Information to assist growers in making informed 

management decisions for Simplot InnateTM potato is available from Association of Official Seed 

Certifying Agencies (AOSCA, 2010).

3.3.4 Requirement of Testing for Simplot InnateTM Potato

During the comment periods for other petitions for nonregulated status, some commenters requested 

USDA to require and provide testing for GE products in non-GE production systems. APHIS notes there 

are no nationally-established regulations involving testing, criteria, or limits of GE material in non-GE 

systems. Such a requirement would be extremely difficult to implement and maintain even if it was 

within APHIS’s regulatory authority to establish this type of system. The inability to implement and 

maintain this type of system makes this potential alternative unreasonable. 

3.4 Comparison of Alternatives 

Table 9 includes a summary of the potential impacts associated with selection of the alternatives 

evaluated in this EA. The potential environmental consequences are presented in Section 4 of this EA.

Table 9. Summary of Issues of Potential Impacts and Consequences of Alternatives

Attribute/Measure Alternative A: No Action Alternative B: Determination 

of Nonregulated Status

Meets Purpose and Need 

and Objectives No Yes

Unlikely to pose a plant 

pest risk

Satisfied through use of 

regulated field trials

Satisfied – risk assessment

(USDA-APHIS, 2013a)

Management Practices

48
Table 9. Summary of Issues of Potential Impacts and Consequences of Alternatives

Attribute/Measure Alternative A: No Action Alternative B: Determination 

of Nonregulated Status

Acreage and Areas of 

Potato Production

Total commercial potato 

production has increased

while land area dedicated to 

potato has decreased. Based 

on potato production trends 

and projections, potatoes will 

continue to be a major crop 

in the U.S. for the 

foreseeable future.

Total acreage dedicated to 

potato is unlikely to change, 

but adoption of Simplot 

InnateTM potato may reduce 

acreage dedicated to 

conventional potatoes.

Agronomic Practices

Agronomic practices will 

remain the same as used 

currently.

Unchanged from No Action 

Alternative

Pesticide Use Pesticides are currently used to 

control insects, nematodes, 

fungi, and weeds.

Unchanged from No Action 

Alternative

Potato Seed Production Potato seed is primarily 

supplied by seed potatoes.

Unchanged from No Action 

Alternative

Organic Potato Production Organic potato growers use 

practices and standards for 

production, cultivation, and 

product handling and 

processing to ensure that their 

products are not pollinated by 

or commingled with 

conventional or GE crops. 

Unchanged from No Action 

Alternative

Environment

49
Table 9. Summary of Issues of Potential Impacts and Consequences of Alternatives

Attribute/Measure Alternative A: No Action Alternative B: Determination 

of Nonregulated Status

Water Resources

The primary cause of

agricultural non-point source

pollution is increased 

sedimentation from soil 

erosion, which can introduce

sediments, fertilizers, and 

pesticides to nearby lakes and 

streams. Agronomic practices 

such as crop nutrient 

management, pest 

management, and conservation 

buffers help protect water

quality from agricultural runoff.

Water usage for irrigation 

would be expected to continue 

to increase.

Unchanged from No Action 

Alternative

Soil Quality

Agronomic practices such as 

crop type, tillage, and pest 

management can affect soil 

quality. Growers will adopt 

management practices to 

address their specific needs in 

producing potatoes. Erosion 

potential may continue to 

increase.

Unchanged from No Action 

Alternative

Air Quality

Agricultural activitiessuch as

burning, tilling, harvesting,

spraying pesticides, and

fertilizing, including the emissions 

from farm equipment, can

directly affect air quality. Aerial

application of herbicides may

impact air quality from drift,

diffusion, and volatilization ofthe

chemicals, as well as motor 

vehicle emissionsfrom airplanes

or helicopters.

Unchanged from No Action 

Alternative

50
Table 9. Summary of Issues of Potential Impacts and Consequences of Alternatives

Attribute/Measure Alternative A: No Action Alternative B: Determination 

of Nonregulated Status

Climate Change

Agriculture-related activities 

are recognized as both direct 

sources of greenhouse gases 

(GHGs)(e.g., exhaust from 

motorized equipment) and 

indirect sources (e.g., 

agriculture-related soil 

disturbance, fertilizer

production.

Unchanged from No Action 

Alternative

Animal Communities

Potato fields may be host to 

many animal and insect 

species. Many of these animals 

are typically considered pests 

and may be controlled by the 

use of integrated pest 

management strategies.

Animals consuming Simplot 

InnateTM tubers may be 

exposed to increased levels 

of glutamine, but this is not 

expected to be detrimental.

Plant Communities

Potatoes are a labor intensive, 

highly managed crop. Members 

of the plant community that 

adversely affect potato 

production may be 

characterized as weeds. Weed 

control is an important aspect 

of potato production. Potato 

growers use production 

practices to manage weeds in 

and around potato fields. 

In the unlikely event of 

hybridization of Simplot 

InnateTM potato with 

conventional varieties, 

resulting progeny may 

contain lowered polyphenol 

oxidase levels. However, this 

is not expected to be 

detrimental. Simplot InnateTM 

potato is no weedier than 

conventional potatoes.

 

Gene Flow

Since potato is primarily 

vegetatively propagated, gene 

flow between cultivars is low. 

Volunteer potatoes would 

continue to need to be 

controlled, although their 

survival is low.

Simplot InnateTM traits are 

not expected to increase 

weediness in potato.

51
Table 9. Summary of Issues of Potential Impacts and Consequences of Alternatives

Attribute/Measure Alternative A: No Action Alternative B: Determination 

of Nonregulated Status

Soil Microorganisms

Abundance and diversity of soil 

microorganisms in and around 

potato fields is expected to 

remain as it is currently. 

Unchanged from No Action 

Alternative

Biological Diversity

The biological diversity in 

potato fields is lower than in 

the surrounding habitats. 

Unchanged from No Action 

Alternative

Human and Animal Health

Risk to Human Health

Glycoalkaloids and patatins 

would continue to pose a risk 

to human health. In the case of 

humans consuming hightemperature cooked potatoes, 

they would continue to be 

exposed to acrylamide.

Glycoalkaloid and patatin 

exposure would continue. 

For humans consuming hightemperature cooked 

potatoes, acrylamide levels 

could be reduced 

approximately 60-70%, which 

would benefit human health.

Risk to Animal Feed

Glycoalkaloids would continue 

to pose a risk to livestock if 

potato stems and foliage are 

fed to them, which is not likely. 

Unchanged from No Action 

Alternative.

Socioeconomic 

Domestic Economic 

Environment

Most potato production is used 

for food. Market utilization 

would likely continue as it is 

currently.

Because of its potential 

human health benefits (lower 

acrylamide) and potential 

reduced wastage (low 

bruising), Simplot InnateTM 

potato may comprise a larger 

share of the domestic potato 

market, and may result in 

increased revenues.

52
Table 9. Summary of Issues of Potential Impacts and Consequences of Alternatives

Attribute/Measure Alternative A: No Action Alternative B: Determination 

of Nonregulated Status

Trade Economic 

Environment

U.S. potatoes and potato 

products will continue to play a 

role in global potato 

production, and the U.S. will 

continue to be a supplier in the 

international market. 

The foreign trade impacts 

associated with a 

determination of 

nonregulated status of 

Simplot InnateTM potatoes are 

anticipated to be similar to 

the No Action Alternative. 

However, import of each 

specific trait requires 

separate application and 

approval by the importing 

country. If the Simplot 

InnateTM traits are approved 

by importing countries, it may 

make up a larger percentage 

of potato import markets.

Other Regulatory Approvals

U.S.

FDA completed consultations, 

EPA tolerance exemptions and 

conditional pesticide 

registrations granted

FDA is currently reviewing 

Simplot’s voluntary 

consultation submission of 

February 12, 2013.

Other countries Countries importing potatoes 

would continue to do so.

Simplot would need to 

obtain regulatory approvals 

from any nations which 

plan to import Simplot 

InnateTM potato.

Compliance with Other Laws

CWA, CAA, EOs Fully compliant Fully compliant 

53
4 ENVIRONMENTAL CONSEQUENCES

4.1 Environmental Consequences

This analysis of potential environmental consequences addresses the potential impact to the human 

environment from the alternatives analyzed in this EA, namely taking no action and a determination by 

the agency that Simplot InnateTM potato does not pose a plant pest risk (Preferred Alternative). 

Potential environmental impacts from the No Action Alternative and the Preferred Alternative for 

Simplot InnateTM potato are described in detail throughout this section. A summary of potential 

environmental impacts is presented in Table 9 (Section 3.4, Comparison of Alternatives). A cumulative 

effects analysis is presented for potentially affected environmental concerns. Certain aspects of this 

product and its cultivation would be no different between the alternatives: those instances are 

described below.

4.2 Scope of Analysis

Potential environmental impacts from the No Action Alternative and the Preferred Alternative for 

Simplot InnateTM potato are described in detail throughout this section. An impact would be any change, 

positive or negative, from the existing (baseline) conditions of the affected environment (described for 

each resource area in Section 2.0). Impacts may be categorized as direct, indirect, or cumulative. A 

direct impact is an effect that results solely from a proposed action without intermediate steps or 

processes. Examples include soil disturbance, air emissions, and water use. An indirect impact may be 

an effect that is related to but removed from a proposed action by an intermediate step or process. 

Examples include surface water quality changes resulting from soil erosion due to increased tillage, and 

worker safety impacts resulting from an increase in herbicide use. 

A cumulative effects analysis is also included for each environmental issue. A cumulative impact may be 

an effect on the environment which results from the incremental impact of the proposed action when 

added to other past, present, and reasonably foreseeable future actions. Examples include breeding 

Simplot InnateTM potato with other deregulated events. If there are no direct or indirect impacts 

identified for a resource area, then there can be no cumulative impacts. Cumulative impacts are 

discussed in Section 5.

Where it is not possible to quantify impacts, APHIS provides a qualitative assessment of potential 

impacts. Certain aspects of this product and its cultivation may be no different between the 

alternatives; those are described below. 

Although the preferred alternative would allow for new plantings of Simplot InnateTM potato to occur 

anywhere in the U.S., APHIS will limit the environmental analysis to those areas that currently support 

potato production. 

54
4.3 Agricultural Production of Potato 

4.3.1 Acreage and Area of Potato Production

Acreage in potato production decreased in recent years, whereas potato yields increased dramatically. 

Potato acres harvested ranged between 1.0 and 1.5 million acres since 1951, with highs of 1.5 million in 

1953, 1966 and 1967 and lows of 1.0 million in 2008, 2009 and 2010 in the United States (USDA NASS 

2012). Per-acre yields, which averaged 397 cwt per acre in 2011 and 401 cwt per acre in 2012 increased 

eight-fold since the early 1900s and doubled since the early 1960s (USDA-NASS, 2013b).

No Action Alternative: Acreage and Area of Potato Production

USDA projects potato production will increase by 4.6 % between 2012 and 2021 (USDA, 2012). Based 

upon historical trends in productivity, this increase in supply is unlikely to result in an increase in potato 

acreage. Therefore, under the No Action alternative, agricultural land used for potato production is 

expected to remain at approximately the same as at present. 

Preferred Alternative: Acreage and Area of Potato Production

If APHIS chooses the Preferred Alternative, some of the Simplot InnateTM potato events may become 

commercially available to the general public. Growers who now purchase conventional varieties of 

Russet Burbank, Ranger Russet and Atlantic potato seed would have the option of purchasing the 

Simplot InnateTM varieties instead of their conventional counterparts. With the reduction in black spot 

bruising and lower levels of reducing sugars, the Ranger Russet may gain more market share, partially 

replacing the Russet Burbank. The lower levels of reducing sugars in the Atlantic potato may result in 

increased market share for that variety, as well.

However, the introduction of these varieties is not expected to have an impact on overall demand for 

potatoes. As described in the petition (Simplot, 2013b), the agronomic characteristics of the ten Simplot 

InnateTM events are essentially the same as their conventional counterparts, and therefore would be 

grown in the same way as their conventional counterparts. The ten Simplot InnateTM potato events do 

not possess traits that would allow them to be grown in areas other than those where their 

conventional counterparts are grown. Therefore, under the Preferred Alternative, acreage dedicated to 

potato would remain about the same.

Simplot’s data demonstrate no differences in morphological characteristics and agronomic requirements 

between Simplot InnateTM potato and other potato cultivars (Simplot, 2013b) and is not likely to change 

land acreage or any cultivation practices for potato production. It is expected that similar agronomic 

practices commonly utilized in commercially available potato cultivars would also be used by growers of 

Simplot InnateTM potato.

55
4.3.2 Agronomic Practices

No Action Alternative: Agronomic Practices

If APHIS chooses the No Action alternative, general production practices are expected to continue as 

they are now. 

Preferred Alternative: Agronomic Practices

The agronomic evaluation of the ten Simplot InnateTM potato events is summarized in Section 7 of the 

petition, with details provided in Appendix 6; analysis of disease susceptibility is presented in petition 

Appendix 8 (Simplot, 2013a). Since all ten Simplot InnateTM potato events are intended for fry and chip 

production, agronomic evaluations were conducted in geographically distinct sites that represent most 

of the main production areas for potatoes destined for fry and chip production in the United States 

(Simplot, 2013b). The agronomic practices and pest control measures employed were location-specific 

and typical for potato cultivation. They were recommended by both regional potato extension 

specialists and field agronomists including soil preparation, fertilizer application, irrigation, cultivation 

and pesticide-based control methods. Events and untransformed varieties received identical inputs and 

treatments at each site. The following characteristics were evaluated over multi-year trials: time to 

emergence, vigor, leaf size, leaf curl, vine maturity, disease susceptibility, insect damage, yield and 

specific gravity. 

In these studies, five events (F37, E12, E24, G11 and H37) exhibited statistically significant increases in 

plant vigor, but the relative difference among the events was small. Five events (F10, F37, E24, G11 and 

H37) demonstrated significant reductions in total yield. There was no obvious correlation between 

decreased yield and increased disease or pest stress except possibly for event G11. Regardless of the 

cause, the potential for reduced yield is expected to impact market acceptability of varieties with these 

genes, and the data do not suggest reduced yield is correlated with increased pest risk (USDA-APHIS, 

2013a).

These trials indicated that no changes to current agronomic practices will be needed to grow the 

potatoes, thus the incorporated traits are not expected to affect agronomic practices. All events 

considered for deregulation were selected to exhibit comparable phenotypic characteristics to the 

control varieties when grown using standard industry practices. There were no differences in disease 

susceptibility that would require additional treatments, nor did the potatoes have different nutrient 

requirements that would alter fertilizer programs. Planting, cultivation, management and harvesting 

processes were not affected by the incorporated traits.

APHIS did not identify any significant changes to agricultural or cultivation practices (e.g. pesticide 

applications, tillage, irrigation, harvesting, etc.) that would result from adoption of the GE crop; 

therefore, no impact on plant diseases or pests or their management is likely to occur (USDA-APHIS, 

2013a).

56
Based on these analyses, if APHIS chooses the preferred Alternative, there would be no expected 

differences in general agronomic practices than if the No Action alternative is chosen.

4.3.3 Potato Seed Production

No Action Alternative: Potato Seed Production

If APHIS chooses the No Action Alternative, potato seed production is expected to continue as it is 

currently.

Preferred Alternative: Potato Seed Production

Since APHIS has determined that agronomic practices will be the same if the petition is approved (USDAAPHIS, 2013a), selection of the Preferred Alternative is not expected to result in any changes in potato 

seed production.

4.3.4 Organic Potato Production

No Action Alternative: Organic Potato Production

In the United States, only products produced using specific methods and certified under the USDA’s 

Agricultural Marketing Service (AMS) National Organic Program (NOP) definition of organic farming can 

be marketed and labeled as “organic” (USDA-AMS, 2010). Organic certification is a process-based 

certification, not a certification of the end product; the certification process specifies and audits the 

methods and procedures by which the product is produced.

The organic sector is rapidly growing both in the U.S. and the European Union (EU). Together, consumer 

purchases in these two regions made up 95 percent of estimated world retail sales of organic food 

products in 2003 (Dimitri and Oberholtzer, 2005). In 2009, world retail sales of organic products were 

estimated to be on the order of $54.9 billion (USD), up from $50.9 billion in 2008 (Organic Monitor, 

2006).

If APHIS chooses the No Action Alternative, organic potato production is expected to continue, but 

trends in production may be affected by unpredictable variables such as demand for both fresh and 

processed organic potatoes, overseas competition and production costs.

Preferred Alternative: Organic Potato Production Practices

Potato cultivar selection and breeding practices are similar between organic and conventional potato 

production. Risks to organic growers would be most likely to occur with accidental mixing of planting 

material or of potatoes in farming, transportation, or processing channels. These risks are the same as 

those that organic growers already experience when keeping their organically grown potatoes separate 

from potatoes grown with conventional methods. Because potatoes are clonally propagated, the risk of 

affecting seed supplies through cross-pollination is negligible. Organic farmers routinely plant organic 

seed potato material and any incidence of cross-pollination in production fields will not affect the 

harvested potatoes. 

57
If APHIS chooses the Preferred Alternative, organic growers would not be expected to modify 

production practices, and so no impacts to organic potato production would be expected.

Some organic potatoes are grown in the same areas as conventional potatoes and some are grown in 

more isolated regions. Based on USDA data, organic potato acreage from 1997 to 2008 showed a 

general increasing trend ranging from a low of 4,335 acres in 1997 to a high of 11,664 in 2007 (USDAERS, 2009).

It is important to note that the current NOP regulations do not specify an acceptable threshold level for 

the adventitious presence of GE materials in an organic-labeled product. The unintentional presence of 

the products of excluded methods will not affect the status of an organic product or operation when the 

operation has not used excluded methods and has taken reasonable steps to avoid contact with the 

products of excluded methods as detailed in their approved organic system plan (Ronald and Fouche, 

2006; USDA-AMS, 2010). However, certain markets or contracts may have defined thresholds (NonGMO-Project, 2010).

4.4 Physical Environment

4.4.1 Water Resources

No Action Alternative: Water Resources

The majority of potato production utilizes irrigation as a water source. As discussed in Section 2.3.1, 

agricultural production can be detrimental to water quality by adding sediments from erosion via 

surface water, and nutrient loading from fertilizers into groundwater. 

If APHIS chooses the No Action alternative, water usage for irrigation would be expected to continue. 

Supplemental irrigation may increase in some areas where potatoes have traditionally been grown 

without irrigation. Potential for water quality impacts will continue.

Preferred Alternative: Water Resources

No changes to agronomic practices which might affect water resources will be necessary to grow 

Simplot InnateTM potatoes (Simplot, 2013b). Simplot’s studies demonstrate no differences in 

morphological characteristics and agronomic requirements between Simplot InnateTM potato and other 

potato varieties (Simplot, 2013b). Again, as with the No Action Alternative, supplemental irrigation may 

increase in some areas where potatoes have traditionally been grown without irrigation, and potential 

for water quality impacts will continue. 

A determination of nonregulated status of Simplot InnateTM potatoes is not expected to change the 

management practices currently employed for potato cultivation. Water quality impacts are expected to 

be the same under the Preferred Alternative as under the No Action Alternative.

58
4.4.2 Soil Quality

No Action Alternative: Soil Quality

Increased erosion potential of soil for potato production may result from fairly high tillage requirements, 

and the small amount of post-crop plant material left in the soil. Cover crops are often planted to help 

mitigate this potential.

Land management practices for potato production can affect soil quality. While practices such as tillage, 

fertilization, the use of pesticides and other management tools can improve soil health, they can also

cause substantial damage if not properly used. Several concerns relating to agricultural practices 

include increased erosion, soil compaction, degradation of soil structure, nutrient loss, increased 

salinity, change in pH, and reduced biological activity (USDA-NRCS, 2001). Methods to improve soil 

quality include careful management of fertilizers and pesticides; use of cover crops to increase plant 

diversity and limit the time soil is exposed to wind and rain; and, increased landscape diversity with 

buffer strips, contour strips, wind breaks, crop rotations, and varying tillage practices (USDA-NRCS, 

2006). Living cover also protects against erosion, provides habitat and substrate for soil organisms, and 

increases soil organic residue inputs (Doran et al., 1996).

If APHIS chooses the No Action alternative, impacts on soil quality are expected to continue.

Preferred Alternative: Soil Quality

A determination of nonregulated status for Simplot InnateTM potato is not expected to change the 

management practices currently employed for potato production. If APHIS chooses the Preferred 

Alternative, potential impacts on soil quality are expected to be similar to those under the No Action 

Alternative. Bruinsma (2003) found no differences in soil attributable to a GE potato cultivar (not this 

trait). Simplot’s studies demonstrate that agronomic characteristics and cultivation practices required 

for Simplot InnateTM potato production are indistinguishable from practices used to grow other potato 

varieties (Simplot, 2013b). Except for the incorporated traits, the ten events are substantially equivalent 

to their conventional counterparts, thus no changes in plant/soil interaction are expected.

If APHIS chooses the preferred alternative, agricultural impacts on soil quality are expected to remain 

the same as they would if the No Action alternative is chosen.

4.4.3 Air Quality

No Action Alternative: Air Quality

If APHIS chooses the No Action alternative, emissions associated with vehicles, fugitive dust particles 

and pesticides are expected to continue.

Preferred Alternative: Air Quality

59
As discussed in Section 2.2.3 Air Quality, emissions associated with crop production include vehicular 

emissions from the use of farm equipment, fugitive dust particles and releases of pesticides. Fugitive 

dust can arise from fields and unpaved roadways and can be generated by disturbance of bare soil 

through vehicle traffic, harvesting operations or wind. These impacts are highly variable across potato 

growing regions and over time, depending on such factors as vehicle type, crop type, utilization of 

pesticides, method of application, soil type and weather conditions.

Simplot’s analyses presented in its petition (Simplot, 2013b) demonstrate that no changes to agronomic 

practices will be required to grow Simplot InnateTM potato. As discussed in Section 2.3.3, agronomic 

practices that could affect air quality, such as soil preparation, cultivation, pesticide application and 

harvesting, were based on practices appropriate for each site, and were the same for the events and the 

controls. The results indicated that no changes from the site-specific practices used for conventional 

varieties would be needed for production of the ten events.

Therefore, if APHIS chooses the preferred alternative, impacts to air quality resulting from this action 

are expected to be the same as if the No Action alternative had been chosen.

4.4.4 Climate Change

No Action Alternative: Climate Change

If APHIS selects the No Action Alternative, impacts to climate change are expected to continue.

Preferred Alternative: Climate Change

The range and area of U.S. potato production is not likely to change under the Preferred Alternative. As 

described in the Simplot petition (Simplot, 2013b) and APHIS PPRA (USDA-APHIS, 2013a), Simplot 

InnateTM potatoes use identical management strategies to those for conventional potato production. 

Therefore, no changes are expected in agricultural activities that might affect climate change, such as 

machine usage and fertilizer application. Collectively, because the range, area, and agronomic practices 

of potatoes are unlikely to change following a determination of nonregulated status of Simplot InnateTM 

potato, the agricultural impacts of potato production on climate change are also unlikely to change 

under the Preferred Alternative.

4.5. Biological Resources

4.5.1 Animal Communities

No Action Alternative: Animal Communities

If APHIS chooses the No Action Alternative, animal communities living both within and outside of potato 

fields are expected to continue to experience impacts similar to the current impacts of agriculture. 

60
Animals living in or near agricultural fields are the most likely to be affected by crop production, 

including aquatic communities, which may be affected by sedimentation and turbidity from erosion, or 

by pesticide runoff. 

Preferred Alternative: Animal Communities

No changes in land use are expected if APHIS chooses the preferred alternative. In addition, the 

evaluation presented in the petition (Simplot, 2013b) demonstrates that changes in agronomic 

practices, including practices related to pesticide use and erosion mitigation, are not required for 

production of Simplot InnateTM potato. In addition, there are a large number of insects that feed on 

potato leaves and other insects that feed on those pests. Many of these insects, including the Colorado 

potato beetle, potato aphid, European corn borer, potato leafhopper and potato psyllid are considered 

pests. The events have not been modified to exhibit any pesticidal activities and do not contain 

pesticide-expressing genes. No differences were observed for insects or other animals interacting 

within the potato ecosystem during the field trials, leading to the conclusion that the Simplot InnateTM 

potatoes would have the same impact on other organisms as conventional potatoes (Simplot, 2013b).

APHIS reviewed Simplot’s data on field trials (USDA-APHIS, 2013a) and impacts by insects, and 

concluded that Simplot InnateTM potato would suffer no greater insect pressure than conventional 

potatoes (USDA-APHIS, 2013a). For example, no increase in aphid infestation or damage was reported 

in the field observations for all ten Simplot InnateTM potato events (Simplot, 2013b). Similarly, although 

aphids are vectors for viruses such as potato virus Y (USDA-APHIS, 2013b), no increase in viral disease 

was reported in field observations for seven of the events (Simplot, 2013b).

In addition, since potatoes are propagated vegetatively from seed potato tuber pieces, pollination by 

bumblebees is not important to potato tuber production. Simplot InnateTM potato has been genetically 

engineered to low acrylamide potential and reduced black spot bruise. Acrylamide only forms after 

cooking potatoes at high heat, so this toxic compound is not expected to be a concern for herbivores. 

Consumption of PPOs by animals would still occur. Phenols occur in wide distribution of plants (Felton

et al., 1989), but their biological function of remains unclear (Bachem et al., 1994; Mayer, 2006). The 

oxidation products of PPO appear to play a role in general plant defense mechanisms against pathogens 

and pests. The relationship between PPO and resistance to herbivores has also been studied. PPO 

activity increases when potato leaves are wounded and at higher rates in response to regurgitant from 

the pest Colorado potato beetle (Kruzmane et al., 2002). In other plants, the increase of PPO activity is a 

direct induced defense against insect pests that decreases nutrient availability (Baldwin and Preston, 

1999; Partington et al., 1999). In addition, PPO in glandular trichomes of wild potatoes (and other 

plants) is involved in resistance to insects (Plaisted, 1980; Steffens, 1994). However, the trichomes of 

cultivated potatoes contain low amounts of PPO which is not thought to be involved resistance to pests 

(Friedman, 1997). Phylogenetic surveys of PPO in land plants shows that the gene family has undergone 

evolutionary expansion in some plant families, but is reduced or absent in others, which suggests that 

61
PPO function is probably diverse (Tran et al., 2012). PPO has also been implicated in other functions 

such as buffering of plastid oxygen levels, wound healing, and chloroplast metabolism (Steffens, 1994).

In potato, PPO is involved in black spot bruise formation, which reduces the quality of harvested tubers

(Bachem et al., 1994; Corsini et al., 1999; Partington et al., 1999). These dark-pigmented polyphenols, 

also referred to as melanins, result in the darkening of potato tissue following mechanical bruising

(Thygesen et al., 1995). 

This suggests that Simplot InnateTM potato is expected to be unchanged relative to PPO gene expression 

and PPO levels in leaves and therefore unchanged in any potential interactions between potato foliar 

PPO and foliar pathogens or pests. No consistent differences were observed in foliar pest and pathogens 

on Simplot potatoes compared to their control varieties (Simplot, 2013b; USDA-APHIS, 2013a). Simplot 

did not assess nematode damage of Simplot InnateTM potato, but Osman et al. (Osman et al., 2012)

suggest that PPO might be involved in resistance to some plant parasitic nematodes, but do not provide 

data demonstrating such a role or address the species that affect potatoes. Conversely, lower PPO levels 

might increase the resistance of Simplot InnateTM potato to some nematodes. Other researchers found 

that tubers of potato cultivars resistant to the potato cyst nematode, Globodera pallida, have lower 

levels of phenols and discolored less than tubers of susceptible cultivars (Mondy et al., 1985). They 

suggest that PPO-mediated tanning of nematode cysts enables eggs to remain viable in soil for a longer 

time. Lyon (Lyon, 1989) reviewed the biochemical basis for resistance of potato to bacterial soft rot 

caused by Erwinia spp. Because it is the dominant monophenol, chlorogenic acid has been a focus in 

many of these studies. Chlorogenic acid did not inhibit the in vitro growth of Erwinia spp. or P. infestans 

(the causal agent of late blight), and there remains no proof that phenols are important in the 

interaction between potato and Erwinia spp. (Lyon, 1989).

Kroner et al. (Kroner and Marnet, 2012) evaluated the role of specific phenolics in quantitative 

resistance to the elicitors of two pathogens, P. infestans, the causal agent of late blight, and 

Pectobacterium atroseptiucm (synonym: E. carotovora subsp. atroseptica), the causal agent of bacterial 

soft rot. Increasing concentrations of total phenolics tended toward a positive correlation with quantity 

of symptoms due to the late blight pathogen, but were negatively correlated with increased tuber rot 

severity due to the soft rot pathogen. Because chlorogenic acid accumulates in response to soft rot 

elicitors, these authors suggest that chlorogenic acid could be used as a marker for resistance to soft rot 

(Kroner and Marnet, 2012). Since chlorogenic acid is a PPO substrate, silencing of PPO would not be 

expected to reduce the level of chlorogenic acid in potato tubers.

Although animals would not be exposed to acrylamide, Simplot InnateTM potato tubers contain increased 

levels of glutamine (Simplot, 2013b) because the enzyme asparagine synthetase also functions to 

deaminate glutamine to glutamate (USDA-APHIS, 2013a). In all of the field trials tested by Simplot, these 

differences were within the 99% tolerance intervals generated from nine non-GE commercial control 

potato varieties grown concurrently at the same field sites (USDA-APHIS, 2013a). Souba (1991) noted 

that in mammalian cells, glutamine acts as a nitrogen donor for the biosynthesis of important 

compounds such as nucleotides and amino acid. Consumption of increased glutamine has been tested 

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by some researchers. For example, Wang et al. (2008) reported that intestinal dysfunction and atrophy 

were prevented when piglets’ diets were supplemented with glutamine. Similarly, Boukhettala et al. 

(2010) showed that adding glutamine to rat diets reduced injury to the intestinal mucosa following a 

course of chemotherapy, and Klimberg et al. (1990) demonstrated that added glutamine protects rat 

intestinal mucosa following radiation therapy.

There were no significant differences between any of the ten events and their respective control 

varieties for mean glycoalkaloid toxin content (Simplot, 2013b). 

RNAi-mediated gene suppression generally requires sequence homology of at least 90% between the 

silencing construct and the target sequence to be successful and even higher degrees of homology over 

21-23 nucleotide stretches (Sharp, 2001). It is not likely that the genetic construct components 

responsible for gene silencing in the Simplot events would contribute to silencing of genes in other nontarget organisms through direct consumption of pollen by pollinators or through secondary exposure of 

beneficial predator or parasitic arthropods or other potential biological control agents for potato pests 

(Sharp, 2001; Lundgren and Duan, 2013) since sequences from arthropods, bacteria, fungi and viruses 

are expected to be highly divergent from the sequences used to silence genes in the Simplot potatoes. 

Furthermore, indirect exposure scenarios are unlikely to lead to impacts to non-target predators and 

parasitic arthropods since 1) they may not receive effective doses, 2) intracellular amplification of siRNA, 

the active gene silencing component derived from dsRNA, is not widely found in insects, 3) 

environmental and physiological conditions in the gut may destroy the RNA, 4) and they may not have 

the appropriate receptors to allow transmembrane movement of dsRNA or the appropriate enzyme to 

direct RNAi (e.g. Dicer, Argonaute, RdRP, RNA and DNA helicases) (Lundgren and Duan, 2013).

The introduced genes did not significantly alter the observed insect pest infestation and disease 

occurrence or resulting damage in Simplot InnateTM potato relative to the control line under the typical 

recommended pest management conditions. Therefore, APHIS concludes that based on the 

compositional similarity of Simplot potato tubers to the parent varieties, the observed interactions of 

Simplot potatoes with insects and pathogens, and the unlikely impacts of nontarget effects due to RNAi, 

that the consumption of or indirect exposure to Simplot tubers or other plant parts is unlikely to have 

adverse impacts on animals in or near potato fields. 

Consumption of Simplot InnateTM potato is unlikely to substantially affect non-target organisms, such as 

mammals, birds, or insects. Simplot data demonstrates that the composition of Simplot InnateTM potato

does not substantially differ from conventional potato varieties (Simplot, 2013b). Simplot indicated that 

they have submitted a safety and nutritional assessment of food and feed derived from Simplot InnateTM 

potato to the FDA on February 12, 2013 (Simplot, 2013b). FDA is presently evaluating the submission. 

There is no evidence that animal exposure to Simplot InnateTM potato would have any effect or be any 

less attractive as food, refuge, cover and nesting sites as non-GE varieties of potatoes. In general, 

migratory birds are not expected to feed on potato plants because of their glycoalkaloid content, while 

cover and nesting sites also appear comparable to conventional varieties because the GE plants are 

agronomically similar.

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The modifications did not alter the quality of potato as food other than lower levels of acrylamide after 

cooking, and lower black spot bruise. There would be no effect from consumption of InnateTM potato 

plant parts because there is nothing different between the plant parts of these varieties and plant parts 

of other potato varieties already in production.

Considering all that is known about Simplot InnateTM potato lines and their production, there is nothing 

to indicate that migratory birds would interact or be affected any differently than they would with other 

potato varieties currently grown.

4.5.2 Plant Communities

No Action Alternative: Plant Communities

If APHIS selects the No Action Alternative, impacts to plant communities as a result of potato production 

are expected to continue. 

Preferred Alternative: Plant Communities

Simplot has presented the results of field trials which demonstrate that Simplot InnateTM potatoes do 

not require any changes to agronomic inputs when compared with conventional potatoes(Simplot, 

2013b). There would be no change in herbicide use or patterns. 

The silencing of acrylamide potential leads to somewhat heightened levels of glutamine in Simplot 

InnateTM potato, but levels are within acceptable limits (OECD, 1997). In the very unlikely event of 

hybridization of Simplot InnateTM potato, resulting progeny may have altered levels of asparagine. Plants 

use asparagine as a nitrogen source when they are unable to store nitrogen in the form of protein, and 

can accumulate to very high concentrations (Halford et al., 2012b).

As discussed in Section 4.5.1, Animal Communities, consumption of Simplot InnateTM potato is not 

expected to change herbivore-plant interactions.

Under the Preferred Alternative, potential impacts to plant communities are not anticipated to be 

different compared to the No Action Alternative.

Land use and agricultural production of potatoes under the Preferred Alternative is likely to continue as 

currently practiced. Consequently, any impact to plant communities as a result of potato production 

practices under the Preferred Alternative is the same as the No Action Alternative.

4.5.3 Gene Flow and Weediness

No Action Alternative: Gene Flow and Weediness

If APHIS selects the No Action Alternative, there would continue to be little problem with gene flow or 

weediness for potato.

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Preferred Alternative: Gene Flow and Weediness

If APHIS selects the Preferred Alternative, no changes in agronomic practices are expected to occur 

(USDA-APHIS, 2013a) which might make potato, including Simplot InnateTM potato more susceptible to 

gene flow or weediness.

4.5.4 Microorganisms

No Action Alternative: Microorganisms

If APHIS chooses the No Action Alternative, potato crop interactions with microorganisms are expected 

to remain the same over time. 

Preferred Alternative: Microorganisms

Under the Preferred Alternative, the impacts to microorganisms are expected to be the same as if the 

No Action Alternative is chosen. The evaluation presented in the petition (Simplot, 2013b) demonstrates 

that changes in agronomic practices, including practices related to soil preparation (which may impact 

soil organic material and pH) and to pesticide application (which may directly impact microorganisms), 

would not be required for production of the ten Simplot InnateTM potato events. The ten Simplot 

InnateTM potato events are substantially similar to conventional potatoes with respect to disease 

susceptibility (USDA-APHIS, 2013a).

Tuber browning can be a plant response to infection by microbial pathogens, so modified potato tubers 

may not to exhibit the same degree of symptoms as conventional varieties. Plant infection can also 

induce the production of other compounds that produce browning (e.g. phenolics) so a complete 

absence of symptoms in GE varieties is unlikely (USDA-APHIS, 2013a). If there are no disease symptoms, 

or if symptoms are reduced below action thresholds, then it is unlikely a farmer would increase pesticide 

use.

A safety assessment of mice fed a diet of GE non-browning potatoes showed no adverse effects in 

mouse gut microbiota (Llorente et al., 2011).

4.4.5 Biodiversity

No Action Alternative: Biodiversity 

If APHIS chooses the No Action alternative, increases in potato productivity are expected to continue to 

offset increased demand, resulting in a fairly constant acreage devoted to potato production in the 

country. This will allow for continued trends of biodiversity occurring outside the borders of agricultural 

fields even though biodiversity. Biodiversity is expected to continue to be fairly low within agricultural 

fields.

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Preferred Alternative: Biodiversity

Under the Preferred Alternative, biodiversity is unlikely to be substantially changed in comparison to the 

No Action Alternative. First, the evaluation presented in the petition (Simplot, 2013b) demonstrates that 

changes in agronomic practices would not be required to incorporate production of the ten events. This 

means cultivation, management, and land-use decisions related to Simplot InnateTM potatoes are not 

different from conventional potato cultivars. Agronomic practices such as irrigation, pesticide 

application, fertilizer applications, and agriculture equipment would be unchanged by the addition of 

these two varieties. Thirdly, flora and fauna that typically inhabit potato fields will continue to be 

affected by currently used management plans and production systems. The consequences of current 

agronomic practices associated with potato production on the biodiversity of plant and animal 

communities are unlikely to be altered.

Consequently, any impact to biodiversity as a result of potato production practices under the Preferred 

Alternative is likely to be identical to the No Action Alternative.

4.6 Human and Animal Health

4.6.1 Human Health 

Potato is primarily grown for human consumption. U.S. per capita potato consumption is approximately 

112 pounds per year. Of this, approximately 65 pounds is used for frozen fries or chips. Per capita 

consumption data are shown in Table 6. As discussed in Section 2.4.1, Human Health, potential toxins in 

potatoes are acrylamide, which forms subsequent to high-temperature cooking, and glycoalkaloids. 

Patatin is allergenic to a very small percentage of children. 

No Action Alternative: Human Health

Under the No Action alternative, consumption of potatoes would be expected to continue at the same 

rate as currently. Consumers will continue to be exposed to similar levels of acrylamide in cooked 

potatoes if other methods are not employed to reduce levels. Glycoalkaloids would be expected to 

remain at sufficiently low levels such that health impacts would not occur. Patatin would remain a 

concern for allergic individuals.

Preferred Alternative: Human Health

If APHIS chooses the Preferred Alternative, and Simplot InnateTM potato is widely adopted, acrylamide 

content in cooked potatoes could be significantly reduced, leading to potential health benefits for 

consumers. Compared with conventional potatoes, Simplot InnateTM potato contains, on average, 58 to 

72 % less acrylamide when cooked (NTP, 2011; Simplot, 2013b). As discussed in Section 2.4.1, Human 

Health, the State of California listed acrylamide as a potential carcinogen under Proposition 65 in 1990 

and established a No Significant Risk Level (NSRL) of 0.2 μg/day (CEPA-OEHHA, 2005), which was later 

revised to 1.0 μg/day (CEPA-OEHHA, 2005). The FDA is considering issuing guidance concerning safety of 

acrylamide (FDA, 2009), and in 2013, published (FDA, 2013b) recommendations that health-conscious 

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consumers may want to avoid the consumption of fried potato products. Especially since American 

consumption of French fries is high (USDA-NASS, 2012c), these developments regarding acrylamide 

safety may lead to processor preference for Simplot InnateTM potato in French fries and other frozen 

potato products. In the absence of these alternative varieties, food producers voluntarily alter their 

production practices to reduce acrylamide in their products. Deployment of these genes would allow 

them an alternative way to produce reduced acrylamide products.

The data presented in the petition shows that the Simplot InnateTM potato events are at least as safe and 

nutritious for food as the untransformed controls (Simplot, 2013b). The compositional analyses of the 

ten events are summarized in the petition, with detailed results in Appendix 9 (Simplot, 2013b). The 

compositional assessments determined the amounts of 1) moisture, protein, total fat, ash, crude fiber, 

carbohydrate and calories; 2) vitamins B6, B3 and C; 3) minerals copper, magnesium and potassium; 4) 

glycoalkaloids; 5) free amino acids; and 6) total amino acids for tubers collected from events grown in 

2009, 2010, and 2011 in potato-growing areas of the United States. Observed changes in ASN and 

reducing sugars accomplished through transformation of various potato varieties resulted in lower 

acrylamide levels in French fries and potato chips. These modifications did not alter the quality of potato 

as food because all results fell within normal ranges for potato. In addition, the research confirmed that 

glycoalkaloid levels were unchanged compared with the control varieties. 

Based on the results in results in the petitioner’s Appendix 9 (Simplot, 2013a), the potato events 

described in this petition do not appear to be compositionally different in comparison to untransformed 

controls, except for the intended traits. Therefore, issues with allergies are not expected to differ from 

those in the currently affected environment or under the No Action alternative. 

The National Academy of Sciences (NAS) has ranked methods of genetic modification according to the 

relative likelihood of unintended effects, such as the increase in a plant’s production of certain allergens. 

The NAS considered methods that involve recombinant DNA via Agrobacterium transfer of genes from 

closely related species (the Simplot InnateTM method used to produce these ten events is one such 

method that does not involve the transfer of genes) to be among the methods least likely to have 

unintended effects – less likely than conventional pollen-based crossing of closely related species – and 

far less likely than methods such as ionizing radiation and chemical mutagenesis, which are not subject 

to regulation and are not excluded methods under the NOP (Sciences, 2004). 

4.6.2 Worker Safety 

No Action Alternative: Worker Safety

If APHIS were to choose the No Action alternative, farm and food production workers would continue to 

be exposed to the same types and amounts of hazards as they currently experience in potato production 

and food processing. 

Preferred Alternative: Worker Safety

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Under the Preferred Alternative, there will be no changes in agronomic or food production practices in 

order to produce food and feed from Simplot InnateTM potato. Consequently, impacts to worker health 

resulting from approval of the petition are expected to be the same as if the No Action Alternative is 

chosen.

Simplot demonstrates in its petition that the agronomic inputs required to cultivate Simplot InnateTM 

potato are functionally equivalent to those required for conventional potatoes (Simplot, 2013b). 

Current health and safety protocols are not likely to require changes to accommodate the production or 

handling of Simplot InnateTM potatoes because the characteristics of the potatoes are not altered. 

Normal harvesting, transport, and storage conditions designed to minimize the accumulation of 

glycoalkaloids and acrylamide do not need to be altered to accommodate these potato varieties. 

4.6.3 Animal Feed

No Action Alternative: Animal Feed

As discussed in Section 2.4.3, Animal Feed, a small portion of the potato crop and waste from processing 

are sold as livestock feed. If APHIS selects the No Action Alternative, a small percent of the potato crop 

would continue to be used for livestock feed.

Preferred Alternative: Animal Feed

The compositional analyses of the ten Simplot InnateTM events are summarized in Section 8 of the 

petition, with detailed results in Appendix 9 (Simplot, 2013b). Additionally, the nutritional and 

compositional differences between Simplot InnateTM potatoes and conventional potatoes were 

evaluated in the USDA-APHIS PPRA (2013a) and found to be similar. The composition of Simplot 

InnateTM potatoes are within the ranges of normal variation with conventional potatoes with respect to 

protein and carbohydrate content available in feed (USDA-APHIS, 2013a). As a result, incorporation of 

Simplot InnateTM potatoes into animal feed is unlikely to affect palatability of the feed. The composition 

of Simplot InnateTM potatoes are within the ranges of normal variation with conventional potatoes with 

respect to protein and carbohydrate content available in feed (USDA-APHIS, 2013a).

In conclusion, the data presented in the petition shows that potatoes from the events are as safe and 

nutritious for feed as the untransformed controls, and if APHIS were to choose the Preferred 

Alternative, the use of potatoes as livestock feed would be no different than if the No Action Alternative 

was chosen.

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4.7 Socioeconomic Impacts

4.7.1 Domestic Economic Environment

No Action Alternative: Domestic Economic Environment

The domestic economic environment is discussed in Section 2.5.1, Socioeconomic: Domestic Economic 

Environment, and potato utilization in the country is summarized in Table 8. Potatoes are grown on 

approximately 1.1 million acres in the United States, with an annual value of approximately $3.5 billion. 

Major products include fresh potatoes, frozen fries and chips. Organic potatoes account for less than 

one percent of the market.

If APHIS chooses the No Action alternative, domestic potato production, including organic production, is 

expected to continue at rates similar to the present. The USDA projects an approximate 4.6 % increase 

in production between 2012 and 2021 (USDA, 2012).

Preferred Alternative: Domestic Economic Environment

If APHIS chooses the Preferred Alternative, the ten Simplot InnateTM potato will become available for 

commercial production. Because of the reduced potential for black spot bruise of Simplot InnateTM 

potato, wastage is expected to decrease. This will lead to greater efficiency in processing, and an 

improved revenue stream for product producers. Overall, if APHIS chooses the Preferred Alternative, 

the introduction of Simplot InnateTM potato are likely to have positive economic impacts on potato 

growers that choose to grow Simplot InnateTM potato.

Potatoes with low acrylamide potential and reduced black spot bruise are expected to have higher 

market value for the same inputs, representing potential increased revenue for growers and processors, 

and an overall increase in the value of potato production. The initial crop introduction will build up 

slowly as seed becomes available and will be controlled within existing processing channels to ensure 

that potatoes enter only the intended markets. This will provide a period of time to assess consumer 

acceptance and to address grower and industry concerns. A limited introduction that is initially in a 

vertically integrated supply chain will be well controlled by grower and processor agreements. In this 

situation, conventional products will be considered “identity preserved” with respect to the wellcontrolled stewardship of the potato event(s) and its products. As adoption of the potato events 

increases, programs for identity preservation will be implemented as needed. It is expected that 

development and implementation of identity preservation systems will add some cost to the supply 

chain; the total costs will depend upon the type and extent of market penetration (Simplot, 2013b). 

Organic potato growers are not anticipated to incur additional operating costs to as a result of the 

Preferred Alternative. See Section 4.3.4 for further discussion.

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4.7.2 Trade Economic Environment

As discussed in Section 2.5.2, Socioeconomic: Trade Economic Environment, the United States exports 

more than $1 billion in potato products annually, primarily consisting of frozen fries and other processed 

potatoes. Demand from Canada, Mexico, and Asia is driving growth in exports. Japan is the largest 

market for U.S. exports of frozen potatoes, while Canada is the largest U.S. export market for chips and 

fresh potatoes. The United States also has substantial imports of potatoes and potato products from 

Canada and Mexico (USDA-ERS, 2012a).

No Action Alternative: Trade Economic Environment

If APHIS chooses the No Action alternative, U.S. potato exports are expected to continue as affected by 

market forces.

Preferred Alternative: Trade Economic Environment

If APHIS chooses the preferred alternative, U.S. potato exports are expected to continue as affected by 

market forces. Approval for the events will be sought in Canada, Japan and Mexico (Simplot, 2013b)

prior to commercial production beginning in the U.S.

Previous recalls of potato products that were shipped to Japan and then found to contain genetically 

modified material were related to unapproved events; Japan has zero tolerance for unapproved events 

(Reuters, 2001). To assist in the prevention of trade disruptions, as has been experienced with other 

potato events, international approvals will be pursued from key trading partner countries prior to 

beginning commercial production in the United States. These approvals should ensure continued trade 

with key export markets. Simplot intends to follow the recommended stewardship policy statement 

released by the Biotechnology Industry Organization in May 2007: 

To help ensure the continued adoption of agricultural biotechnology globally and to continue to 

have products of agricultural biotechnology bring value to the marketplace, BIO’s Food and 

Agriculture Section supports actions that facilitate the flow of goods in commerce and minimize 

trade disruptions. BIO’s Food and Agriculture Section believes that henceforth individual 

member companies should, prior to commercialization meet applicable regulatory requirements 

in key countries identified in a market and trade assessment that have functioning regulatory 

systems and are likely to import the new biotechnology-derived plant products.

The voluntary guideline was adopted because, according to BIO “asynchronous authorizations combined 

with importing countries maintaining ‘zero tolerance’ for recombinant-DNA products not yet authorized 

results in the potential for major trade disruptions. The potential occurrences of trade disruptions will 

only increase given the substantial amount of research that will bring many new products and 

combinations of products to market.”

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In comparison to some biotech crops, the Simplot InnateTM potato is expected to be viewed more 

favorably by regulatory organizations due to the lack of pesticidal traits and marker-free transformation 

methods. For these reasons, it is anticipated to pose fewer implications for export markets. 

If APHIS chooses the preferred alternative, as with the domestic economic environment, the 

introduction of these potato events may have positive economic impacts on export markets, recognizing 

that some additional costs could be incurred. 

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5 CUMULATIVE IMPACTS

A cumulative impact may be an effect on the environment which results from the incremental impact of 

the proposed action when added to other past, present, and reasonably foreseeable future actions. For 

example, the potential effects associated with a determination of nonregulated status for a GE crop in 

combination with the future production of crop seeds with multiple deregulated traits (i.e., “stacked” 

traits), including drought tolerance, herbicide tolerance, and pest resistance, would be considered a 

cumulative impact. 

Regulations promulgated by the Council on Environmental Quality (CEQ) under the National 

Environmental Policy Act (NEPA) define cumulative impact as “the impact on the environment which 

results from the incremental impact of the action when added to other past, present and reasonably 

foreseeable future actions” (40 CFR 1508.7). For example, the potential effects associated with a 

determination of nonregulated status of a GE crop in combination with the future production of crop 

plants with multiple traits that are no longer subject to the regulatory requirements of 7 CFR Part 340 or 

the plant pest provisions of the Plant Protection Act, including disease tolerance, nitrogen utilization, 

and herbicide tolerance, would be considered a cumulative impact.

5.1 Assumptions Used for Cumulative Impacts Analysis

Cumulative effects are qualitatively analyzed for each environmental issue assessed in Section 4, 

Environmental Consequences by focusing on the Preferred Alternative in consideration of related

activities including past, present and reasonably foreseeable future actions including the production of 

potato progeny. In this analysis, if there are no direct or indirect impacts identified by a resource area, 

then APHIS assumes there can be no cumulative impacts in that area. 

APHIS considered the potential for Simplot InnateTM potato to extend the range of potato production 

and affect the conversion of land to agricultural purposes. Simplot’s studies demonstrate that 

agronomic characteristics and cultivation practices required to produce Simplot InnateTM potato are 

indistinguishable from practices used to grow conventional potatoes (Simplot, 2013b; USDA-APHIS, 

2013a). This implies its cultural requirements would neither differ from other potatoes nor change the 

areas where potatoes are currently grown. If the petition is approved, Simplot InnateTM potato could 

replace other commercially available potato cultivars, without requiring production on new, previously 

non-cropped land. Land use changes associated with approving the petition do not appear to be any 

different than those associated with conventional potato production. APHIS focused the analysis of 

cumulative impacts on the areas in the U.S. that currently produce potatoes.

Potential reasonably foreseeable cumulative effects are analyzed under the assumption that some 

growers have used commonly accepted best management practices (BMPs) in the past, and would 

continue to use these practices when reasonable under the circumstances for their chosen system and 

cultivars during potato production. APHIS recognizes, however, that not all growers choose to use the 

same BMPs. 

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5.2 Past and Present and Reasonably Foreseeable Actions

The Preferred Alternative is not expected to directly cause a measurable change in agricultural acreage 

or area devoted to potato production in the United States. The analysis showed Simplot InnateTM potato 

is another potato cultivar that is agronomically and compositionally similar to other commercially 

available potato cultivars, so it is expected that Simplot InnateTM potato would replace other similar 

cultivars without expanding the acreage of area devoted to potato production. There is no reason to

anticipate changes to the availability of non-GE potato cultivars on the market based on the entry of this 

variety into the market.

Approving the petition for a determination of nonregulated status for Simplot InnateTM potato is not 

expected to change current potato production practices. Studies conducted by Simplot demonstrate the

agronomic characteristics and cultivation practices of Simplot InnateTM potato are indistinguishable from 

practices used to grow other potato cultivars (Simplot, 2013b; USDA-APHIS, 2013a). Consequently, 

progeny bearing these genes also appear unlikely to require different practices.

Organic growers use common practices to maintain the organic status in their potato production,

including employing adequate isolation distances between the organic potato field and the fields of 

neighbors to minimize the chance that pollen will be carried among fields. Given the importance of 

maintaining varietal traits and consumer recognition and preference for specific potato cultivars, the 

separation of production and processing of potatoes by cultivars is routinely utilized by growers, packers 

and retailers in the United States market to satisfy consumer preference and demand. Availability of 

another potato cultivar, such as Simplot InnateTM potato under the Preferred Alternative, is not expected 

to impact the organic production of potatoes any differently than other potato cultivars currently being 

grown. Progeny bearing these genes may become deliberately added to specific potato cultivars based 

on market demand, and the choice to produce those modified varieties remains with each individual 

farmer.

Based on the information described in Section 4.7.1, Domestic Trade Environment, APHIS concludes that 

a determination of nonregulated status of Simplot InnateTM potato will have no foreseeable adverse 

cumulative effects on domestic commerce. Simplot InnateTM potato has the potential to improve potato 

processing capabilities and also improve the economics of potato processing and consumer nutrition. 

There may also be a reduction in cost of processing associated with a reduction in potato browning and 

in providing alternatives to conventional technologies to prevent browning. Progeny bearing these 

genes are anticipated to have the same potential for benefits. Based on these factors, no net negative 

cumulative impacts on domestic economics are identified associated with the production of Simplot 

InnateTM potato.

Approving the petition for a determination of nonregulated status to Simplot InnateTM potato would 

have the same impacts to water, soil, air quality, and climate change as that of potato cultivars currently 

available. Agronomic practices that have the potential to impact soil, water and air quality, and climate 

change would not change because Simplot InnateTM potato is agronomically similar to other potato 

73
cultivars. Because of its similarity to other potato cultivars, adoption of Simplot InnateTM potato is 

expected to replace other similar cultivars without impacting water, soil, air quality, and climate change

differently from other potato varieties. Cumulative impacts due to climate change are anticipated to be 

the same for Simplot InnateTM events and conventional potatoes because their agronomic characteristics 

remain similar. Additionally, potato production in the United States occurs on less than one percent of 

the acreage as compared to the acreage occupied by corn and soybeans (USDA NASS, 2012b) so the 

magnitude of any climate change due to potato production changes appears unlikely to be detectable. 

Cumulative impacts of the Preferred Alternative to microorganisms and biodiversity are not expected to

be significantly different than under the No Action Alternative because Simplot InnateTM potato is 

agronomically and compositionally similar to other potato cultivars. 

Cumulative impacts to plant communities resulting from gene flow or weediness potential would be the 

same for Simplot InnateTM potato events and conventional potatoes based on multiple years of field 

data, compositional analysis, and a lack of changes in agronomic inputs (including pesticides and 

herbicides). Gene flow from potatoes, whether biotech or conventional, is unlikely due to the cropping 

practices of rotation and the clonal propagation of potato varieties in U.S. agriculture. Consequently, 

this variety does not present a safety risk, or pose an increased weediness risk in relation to other 

currently available potatoes based on the information summarized in the PPRA (USDA-APHIS, 2013a). 

Cumulative impacts to animal communities would be the same for Simplot InnateTM potato events and 

conventional potatoes. Three years of field data as well as compositional analysis and molecular stability 

show that Simplot InnateTM potato events are equivalent to conventional potatoes (Simplot, 2013b). 

Even in cases where asparagine was lower (for reducing acrylamide), the levels were still within the 

combined literature ranges. In addition, no changes were observed in land use or agronomic inputs 

including pesticides. Animals consuming Simplot InnateTM potato may be exposed to increased levels of 

glutamine, but research on dietary supplementation with glutamine has not had any negative animal 

health effects. In the future, multiple potato varieties carrying these genes may lead to an increased risk 

of exposure to increased levels of glutamine, but consumers are more likely to substitute varieties 

rather than increasing their potato consumption.

In general, cumulative effects on human consumer health are expected to be the same for Simplot 

InnateTM potato events and conventional potatoes. There is one major exception: the Simplot InnateTM 

potato contains significantly less acrylamide-forming potential than conventional potatoes. Reduced 

levels of acrylamide in cooked potatoes are associated with human health benefits in consumers. 

Reduced potential to form acrylamide should result in significant human health benefits, particularly for 

those with a diet high in potato products produced by cooking at high temperatures. Compared with 

the conventional varieties, Simplot InnateTM potato contained on average 58 to 72 percent less 

acrylamide (Simplot, 2013b). Adoption of these potatoes could result in a significant reduction in 

dietary intake of acrylamide and decrease exposure to this naturally occurring substance found to cause 

cancer in laboratory animals (NTP, 2011).

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In addition, total protein and glycoalkaloid levels in Simplot InnateTM potato were unchanged compared 

with the control varieties (Simplot, 2013b). Although patatin was not measured during the studies

(Simplot, 2013b), any potential exposure to patatin is not expected to be different under the Preferred 

Alternative than under the No Action Alternative. Some allergies have been detected in children as a 

result of patatin; however, these allergies are only in children and are uncommon (De Swert et al., 2002; 

2007). Children who are allergic to potatoes would avoid potatoes under the No Action Alternative;

therefore, any changes in patatin levels in Simplot InnateTM potato would not impact these children, as 

they are already avoiding potatoes due to the high proportion of patatin already occurring in 

conventional potato varieties (Mignery et al., 1988). 

Cumulative impacts to worker safety would be expected to be the same for Simplot InnateTM potato 

events and conventional potatoes because the agronomic practices are not expected to change.

Livestock consuming raw potatoes are not expected to realize any health benefits from reduced 

acrylamide-forming potential in these potatoes. Simplot submitted a safety and nutritional assessment 

of food and feed derived from Simplot InnateTM potato to the FDA on date February 12, 2013(BNF No. 

141). The FDA is presently evaluating the submission. There are no changes in food and feed safety 

expected to occur under the Preferred Alternative. 

Cumulative impacts on the domestic economic environment generally would be similar for Simplot 

InnateTM potato events and conventional potatoes, although some economic impact is expected because 

of the potential health benefits associated with these new potatoes. These events grow similarly and 

have similar biochemical composition to conventional potatoes, however, the low acrylamide, reducing 

sugars, and black spot bruise traits add value that could increase the price received for these potatoes. 

Potatoes with low acrylamide potential and reduced black spot bruise are expected to have higher 

market value for the same inputs, representing potential increased revenue for growers and processors, 

and an overall increase in the value of potato production. To the extent that these traits become 

incorporated into many other existing varieties, this added market value is anticipated to diminish. 

Cumulative impacts to the trade economic environment generally would be similar for Simplot InnateTM 

events and conventional potatoes, unless the potential health benefits become an important factor in 

international marketing. Increased demand is expected to lead to increased supply of these potatoes, 

but to the extent that other countries indiscriminately block importation of GE foods, these 

opportunities may be missed.

Introduction of Simplot InnateTM potato will require channeling of the new potatoes into the desired 

markets. The careful supply chain introduction would be similar to all potato variety management 

systems already in place for product purity. It is expected that development and implementation of 

identity preservation systems will add some cost to the supply chain; the total costs will depend upon 

the type and extent of market penetration (Simplot, 2013b). The Simplot InnateTM potato could have 

cumulative economic impacts on the domestic potato market and procedures developed to manage 

product purity in the supply chain.

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Upon introduction, procedures will be implemented to prevent unintended mixing of Simplot InnateTM 

with conventional potatoes as part of the stewardship program. In addition, Simplot is seeking 

international regulatory approvals in areas such as Japan and Mexico for import approval. Also, approval 

in Canada is being sought for import and cultivation. Approval in these key trading countries will 

minimize market disruption should a low-level presence of Simplot InnateTM potatoes be found in the 

market from accidental mixing. The Simplot InnateTM potatoes could have cumulative trade economic 

impacts on the potato export market and procedures developed to manage product purity in the supply 

chain.

Simplot InnateTM potato, and the deployment of the genes in this variety, may offer protection against 

black spot bruise, slight changes in reducing sugars, and reduced acrylamide potential. During 

processing, potatoes are routinely culled due to black spot bruise when making French fries or potato 

chips, however, with Simplot InnateTM potato, fewer potatoes will be lost to black spot bruise, resulting 

in less waste. As a result of increased usable yield per pound existing production becomes more 

efficient, so less acreage can meet the demand for potatoes. Reductions in potato acreage are 

associated with fewer agricultural inputs and concomitant environmental benefits with associated 

positive environmental impacts related to land use and agricultural inputs. For the purposes of this

cumulative impacts discussion, however, it is conservatively assumed that land use and agronomic 

inputs would potentially decline or remain the same, and are unlikely to increase.

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6 THREATENED AND ENDANGERED SPECIES

The Endangered Species Act (ESA) of 1973, as amended, is one of the most far-reaching wildlife 

conservation laws ever enacted by any nation. Congress passed the ESA to prevent extinctions facing 

many species of fish, wildlife and plants. The purpose of the ESA is to conserve endangered and 

threatened species and the ecosystems on which they depend as key components of America’s heritage. 

To implement the ESA, the U.S. Fish & Wildlife Service (USFWS) works in cooperation with the National 

Marine Fisheries Service (NMFS), other Federal, State, and local agencies, Tribes, non-governmental 

organizations, and private citizens. Before a plant or animal species can receive the protection provided 

by the ESA, it must first be added to the Federal list of threatened and endangered wildlife and plants.

A species is added to the list when it is determined by the USFWS/NMFS to be endangered or 

threatened because of any of the following factors:

• The present or threatened destruction, modification, or curtailment of its habitat or range;

• Overutilization for commercial, recreational, scientific, or educational purposes;

• Disease or predation;

• The inadequacy of existing regulatory mechanisms; and

• The natural or manmade factors affecting its survival.

Once an animal or plant is added to the list, protective measures apply to the species and its habitat. 

These measures include protection from adverse effects of federal activities. 

Section 7 (a)(2) of the ESA requires that federal agencies, in consultation with USFWS and/or the NMFS, 

ensure that any action they authorize, fund, or carry out is “not likely to jeopardize the continued 

existence of a listed species or result in the destruction or adverse modification of designated critical 

habitat.” It is the responsibility of the federal agency taking the action to assess the effects of their 

action and to consult with the USFWS and NMFS if it is determined that the action “may affect” listed 

species or designated critical habitat. To facilitate their ESA consultation requirements, APHIS met with 

the USFWS from 1999 to 2003 to discuss factors relevant to APHIS’ regulatory authority and effects 

analysis for petitions for nonregulated status and developed a process for conducting an effects 

determination consistent with the Plant Protection Act (PPA) of 2000 (Title IV of Public Law 106-

224). APHIS uses this process to help fulfill its obligations and responsibilities under Section 7 of 

the ESA for biotechnology regulatory actions. 

APHIS met with USFWS officials on June 15, 2011, to discuss whether APHIS has any obligations under 

the ESA regarding analyzing the effects of herbicide use associated with all GE crops on TES. As a result 

77
of these joint discussions, USFWS and APHIS have agreed that it is not necessary for APHIS to perform 

an ESA effects analysis on herbicide use associated with GE crops currently planted because EPA has 

both regulatory authority over the labeling of pesticides and the necessary technical expertise to assess 

pesticide effects on the environment under FIFRA. APHIS has no statutory authority to authorize or 

regulate the use of pesticides used by potato growers. Under APHIS’ current Part 340 regulations, 

APHIS only has the authority to regulate the InnateTM potato or any GE organism as long as APHIS 

believes they may pose a plant pest risk (7 CFR § 340.1). APHIS has no regulatory jurisdiction over any 

other risks associated with GE organisms including risks resulting from the use of herbicides or other 

pesticides on those organisms. 

After completing a plant pest risk analysis, if APHIS determines that seeds, plants, or parts thereof from 

Simplot InnateTM potato do not pose a plant pest risk, then these articles would no longer be subject to 

the plant pest provisions of the PPA or to the regulatory requirements of 7 CFR Part 340, and therefore, 

APHIS must reach a determination that these articles are no longer regulated. As part of its EA analysis, 

APHIS is analyzing the potential effects of these potato events on the environment including, as 

required by the ESA, any potential effects to threatened and endangered species and critical habitat. 

As part of this process, APHIS thoroughly reviews the GE product information and data related to the 

organism (generally a plant species, but may also be other genetically engineered organisms). For each 

transgene/transgenic plant, APHIS considers the following: 

• A review of the biology and taxonomy of the crop plant and its sexually compatible relatives;

• Characterization of each transgene with respect to its structure and function and the nature 

of the organism from which it was obtained;

• A determination of where the new transgene and its products (if any) are produced in the 

plant and their quantity;

• A review of the agronomic performance of the plant, including disease and pest 

susceptibilities, weediness potential, and agronomic and environmental impacts;

• Determination of the concentrations of known plant toxicants (if any are known in the 

plant);

• Analysis to determine if the transgenic plant is sexually compatible with any threatened or 

endangered species (TES) of plants or a host of any TES; and

• Any other information that may inform the potential for an organism to pose a plant pest 

risk.

In following this review process, APHIS, as described below, has evaluated the potential effects that a 

determination of nonregulated status of the potato events may have, if any, on federally-listed TES 

species and species proposed for listing, as well as designated critical habitat and habitat proposed for 

designation.

Based upon the scope of the EA and production areas identified in the Affected Environment section of 

the EA, APHIS reviewed the USFWS list of TES species (listed and proposed) for each state where potato 

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is commercially produced from the USFWS Environmental Conservation Online System (ECOS; as 

accessed February 19, 2014 at http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrence.jsp) , 

(USDA-APHIS, 2014c; 2014a). Prior to this review, APHIS considered the potential for Simplot InnateTM 

potato to extend the range of potato production and also the potential to extend agricultural 

production into new natural areas. APHIS has determined that agronomic characteristics and 

cultivation practices required for Simplot InnateTM potato are essentially indistinguishable from 

practices used to grow other potato varieties (Simplot, 2013b; USDA-APHIS, 2013a). Simplot InnateTM 

potato may be expected to replace other varieties of potato currently cultivated, and APHIS does not 

expect the cultivation of Simplot InnateTM potato to result in new potato acres to be planted in areas 

that are not already devoted to agriculture. Accordingly, the issues discussed herein focus on the 

potential environmental consequences of the determination of nonregulated status of Simplot InnateTM 

potato on TES species in the areas of the US where potatoes are currently grown.

JR Simplot has used a genetic engineering approach to introduce into the background of commercial 

potato cultivars two traits that are of interest to potato consumers, producers and processors: reduced 

acrylamide potential in certain processed or heated potato products and reduced black spot bruise 

(Simplot, 2013b). Simplot used the single construct pSIM1278 to transform 5 different commercial 

parent varieties and created the ten events described in the petition. The objective was to incorporate 

the same new phenotypes into each of these important varieties, while maintaining all of the desirable 

characteristics originally selected by potato breeders (Simplot, 2013b). Unlike most GE agricultural 

products that have been commercialized to date, the transformation in this instance does not result in 

production of proteins. The inserted DNA contains silencing cassettes that, when expressed, generate 

variably-sized and unprocessed transcripts. These transcripts trigger the degradation of mRNAs that 

would normally code for an enzyme, like asparagine synthetase. This results in much reduced levels of 

the targeted “silenced” enzymes (Simplot, 2013b). As described in the petition and PPRA, the potato 

lines were transformed to silence four different genes in potato: asparagine synthetase-1 (Asn1), 

polyphenol oxidase-5 (Ppo5), potato phosphorylase L (PhL) and the starch-associated R1 gene (R1). The 

suppression of Asn1 results in potatoes with reduced free asparagine, and the suppression of PhL and 

R1 results in potatoes with a lower content of reducing sugars. Collectively, the silencing of these 3 

genes should result in potato tubers with a reduced acrylamide potential. The suppression of Ppo5

confers the Simplot InnateTM potato with a non-browning phenotype resulting in tubers with reduced 

black spot bruising(Simplot, 2013b), (USDA-APHIS, 2013a). 

For its analysis on TES plants and critical habitat, APHIS focused on the agronomic differences between 

Simplot InnateTM potato and potato varieties currently grown; the potential for increased weediness; 

and the potential for gene movement to native plants, listed species, and species proposed for listing. 

For its analysis of effects on TES animals, APHIS focused on the implications of exposure to Simplot 

InnateTM potato, and the potential for an effect resulting from the gene silencing activity that sets 

Simplot InnateTM potato apart from other potato lines currently in production. 

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6.1 Potential Effects of Simplot InnateTM Potato on TES and Critical Habitat

Threatened and Endangered Plant Species and Critical Habitat

The agronomic and morphologic characteristics data provided by JR Simplot were used in the APHIS 

analysis of the weediness potential for Simplot InnateTM potato, and further evaluated for the potential 

to impact TES and critical habitat. Agronomic studies conducted by JR Simplot over several years tested 

the hypothesis that there would be no change in agronomic practices used to produce Simplot InnateTM 

potato in comparison with conventional potato (Simplot, 2013b). Agronomic evaluations were 

conducted in geographically distinct sites selected to represent most of the main production areas for 

each of the five varieties. Characteristics evaluated included time to emergence, vigor, leaf size, leaf 

curl, vine maturity, disease susceptibility, insect damage, yield, specific gravity, and abiotic stressors 

(frost, hail, heat, herbicide, and wind) (Simplot, 2013b). Five events (F37, E12, E24, G11 and H37) had 

statistically significant increased plant vigor, but the relative difference was small. Five events (F10, F37, 

E24, G11 and H37) had significant reductions in total yield. There was no obvious correlation between 

decreased yield and increased disease or pest stress except possibly for event G11, since greater insect 

stress was observed than in the parental control at four of 48 insect observations on this event. Event 

J55 had significantly reduced early emergence (Simplot, 2013b). However, no differences were detected 

between the transformed potato lines and conventional potato in growth, reproduction, or interactions 

with pests and diseases, that would indicate a significant change in agronomic practices would be 

necessary for the commercial production of these transformed lines (Simplot, 2013b). 

Potatoes are not known to be weedy or persistent; they are incapable of survival outside of cultivation 

(Holm et al., 1979; Muenscher, 1980; Love, 1994; OECD, 1997). Potato tubers have a fairly low frost 

tolerance; shallow tubers and those exposed to the surface are often destroyed by frost, but in 

temperate climates up to 20% of tubers left in the soil show no dormancy and will sprout the next 

season (Andersson and de Vicente, 2010). Volunteer potatoes, growing from overwintered tubers, can 

be a weed problem in the following crop but are easily controlled with cultivation and herbicides and do 

not persist as weeds for more than a few years (Andersson and de Vicente, 2010). 

The data presented by Simplot demonstrate that Simplot InnateTM potato is, for the most part,

phenotypically and agronomically similar to the respective parent varieties and do not exhibit 

meaningful changes in characteristics that would make them weedier or more persistent than their 

respective parent varieties (Simplot, 2013b). Because of the reductions in emergence and yield, some of 

the Simplot InnateTM potato events appear to have a reduced potential for weediness (USDA-APHIS, 

2013a). Furthermore, JR Simplot did not observe any differences during the completed post-harvesting 

volunteer monitoring of the Simplot InnateTM potato field test sites from 3 years of field testing that 

would indicate that these potatoes have properties that would increase their survivability compared to 

conventional potatoes. Volunteers were rarely observed, were easily controlled, and are not 

engineered for resistance to herbicides (Simplot, 2013b). Based on the agronomic field data and 

literature survey concerning weediness potential of the crop, APHIS has determined that the Simplot 

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InnateTM potato is unlikely to persist as a troublesome weed or to have an impact on current weed 

management practices (USDA-APHIS, 2013a).

APHIS evaluated the potential of Simplot InnateTM potato to cross with native plants and listed species, 

and the possibility that such crosses could result in hybrids that could affect critical habitat. As 

discussed thoroughly in sections 2.4.3 and 4.4.3 Gene Flow and Weediness, APHIS has determined that 

there is little risk of gene flow to related plant species and no risk to unrelated plant species from the 

cultivation of Simplot InnateTM potato. The events derived from Russet Burbank produces few flowers 

and is male sterile, and those derived from variety “H” are completely sterile (Simplot, 2013b). The 

events derived from Ranger Russet, Atlantic, and “G” are likely to produce fertile pollen, but this should 

have little consequence in regards to gene flow to related plants. Among native Solanum spp. in the US, 

cultivated potato is potentially sexually-compatible only with two tuber-bearing species, S. jamesii and 

S. stoloniferum (previously S. fendleri (Spooner et al., 2004). These two species are found only in Texas, 

New Mexico, and Arizona, and S. jamesii is further found in Colorado and Utah. In some cases these 

species are found in counties with commercial potato production (Simplot, 2013b), (USDA-NRCS, 2013b; 

2013a) As discussed thoroughly in the PPRA, numerous biological and geographic obstacles make gene 

flow from these cultivated potato varieties to the two wild relatives a highly unlikely occurrence, and 

there have been no reports that such crosses have ever occurred naturally (Love, 1994). However, 

because it is scientifically plausible that cultivated potatoes could hybridize with S. stoloniferum, the 

PPRA considered the potential impact on the weediness of S. stoloniferum if gene introgression from

Simplot InnateTM potato were to occur. The resulting analysis concluded that the novel phenotypes (low 

acrylamide potential and reduced black spot bruise) did not impart any significant change in the 

agronomic properties or response to biotic or abiotic stresses that would cause them to be more weedy

(USDA-APHIS, 2013a).

A review of the USFWS database of listed species indicates that there are three species of the 

Solanaceae family in the genus Solanum that are listed as endangered. Aiakeakua popolo (S. 

sandwicense) and popolo ku mai (S. incompletum) both found only in Hawaii, and Erubia (S. 

drymophilum) found only in Puerto Rico. There are also two candidate species: popolo (S. nelsonii) 

found only in Hawaii, and marron bacora (S. conocarpum) found only in the U.S. Virgin Islands (USFWS, 

2014a). Crosses between these species and Simplot InnateTM potato would be highly unlikely because 

these species are not found in areas of potato production and even if they were found together, crosses 

would be unlikely because the biology of potato as described in sections 2.4.3 and 4.4.3 Gene Flow and 

Weediness, and in the PPRA (USDA-APHIS, 2013a). 

Based on agronomic field data, literature surveyed on potato weediness potential, and the unlikelihood 

of crosses with wild relatives, APHIS has concluded that Simplot InnateTM potato will have no effect on 

threatened or endangered plant species or critical habitat.

Threatened and Endangered Animal Species

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For its effects analysis on TES animal species, APHIS focused on the likelihood of species to be exposed 

to Simplot InnateTM potato and possible effects that could occur as a result of such contact. Exposure of 

TES species to Simplot InnateTM potato is only likely if the species occur in the areas where potato is 

grown, because potato plant parts (seeds, tubers, pollen, vegetation, crop debris) are not readily 

transported long distances without human intervention. Threatened and endangered animal species 

that may be exposed to Simplot InnateTM potato would be those TES that inhabit potato fields and may 

feed on Simplot InnateTM potato. Few if any TES are likely to use potato fields because they do not 

provide suitable habitat. In general, the majority of threatened and endangered species are found in 

more natural habitats (USFWS, 2011).

Little information can be found concerning threatened or endangered species in farm fields, especially 

potato fields. In an Environmental Assessment on the use of genetically engineered corn and soybean in 

refuges in the mid-west, the USFWS reported that whooping crane (Grus americana), sandhill crane 

(Grus canadensis pulla), piping plover (Charadrius melodus), interior least tern (Sterna antillarum), and 

Sprague’s pipit (Anthus spragueii; a candidate species) occasionally feed in farmed sites (USFWS, 2011). 

Although it is possible that these bird species may visit potato fields during migratory periods, it is 

unlikely they would be present during normal farming operations (USFWS, 2011). USDA-APHIS Wildlife 

Services has received complaints for damage to corn, wheat, and potatoes caused by sandhill cranes

(USDA-APHIS, 2013c).

As discussed in Section 2.4.1, Animal Communities, there are few animals reported to consume potato 

plants in an agricultural setting. This is not surprising considering the foliage and stems of potato 

contain toxic glycoalkaloids known to cause illness when consumed (Sinden, 1987). Known exceptions 

are whitetail deer, wild boar, and voles (Marinette County, 2014), (O'Brien, 2005; Taylor, 2014). There 

are two listed sub-species of white-tailed deer and three listed vole species within States that have

commercial potato production. The Columbia white-tailed deer (Odocoileus virginianus leucurus) has 

two populations; one population in Douglass County, Oregon was delisted in 2003. The other, listed as 

endangered, is located in the lower Columbia River Valley in Washington State (USFWS, 1983). Neither 

population is found in areas of significant potato production as indicated in Figure 1, Potato Growing 

Regions of the U.S. (USDA-NASS, 2007). The endangered Key deer (Odocoileus virginianus clavium) is 

found only on the extreme tip of southern Florida far from any commercial potato production (USFWS, 

2014c). The three vole species are listed as endangered. The Amargosa vole (Microtus californicus 

scirpensis) is found in Inyo County in southeast California which is not an area of potato production 

(USFWS, 2014b). The Florida salt marsh vole (Microtus pennsylvanicus dukecampbelli) is found in 

saltmarshes of Levy County in coastal Florida, also not in areas of potato production (USFWS, 2014d). 

The Hualapai Mexican Vole (Microtus mexicanus hualapaiensis) is found in Mohave County, Arizona, 

where potatoes are a minor crop. However, the species would be unlikely to be found in potato fields 

because it is found only in woodlands and grasslands in the canyons of the Hualapai Mountains (USFWS, 

1991). 

Although unlikely, APHIS considered the possible effects on TES if they were to consume Simplot 

InnateTM potato. Detailed compositional analyses of the ten events are found in Appendix 9 of the 

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petition. The compositional assessments determined the amounts of 1) moisture, protein, total fat, ash, 

crude fiber, carbohydrate and calories; 2) vitamins B6, B3 and C; 3) minerals copper, magnesium and 

potassium; 4) glycoalkaloids; 5) free amino acids; and 6) total amino acids for tubers collected from 

events grown in 2009, 2010, and 2011 in potato-growing areas of the United States (Simplot, 2013b). 

The potato events described in the petition were found to be no different compositionally when 

compared to untransformed controls, except for the intended traits (Simplot, 2013b). As discussed in 

Section 4.6.1, Human Health, issues with allergies to Simplot InnateTM potato would be unlikely beyond 

what individuals with potato allergies would normally experience. The modifications did not alter the 

quality of potato as food other than lower levels of acrylamide after cooking, and lower black spot 

bruise. Simplot submitted a safety and nutritional assessment of food and feed derived from Simplot 

InnateTM potato to the FDA on February 12, 2013 (BNF No. 141) (Simplot, 2013b). FDA is presently 

evaluating the submission. 

As discussed in Section 4.4.1, Animal Communities, there are a large number of insects that feed on 

potato leaves and other insects that feed on those pests. No differences were observed for insects or 

other animals interacting within the potato ecosystem during the field trials, leading to the conclusion 

that Simplot InnateTM potatoes would have the same impact on other organisms as conventional 

potatoes (Simplot, 2013b). There is no evidence that animal exposure to Simplot InnateTM potato would 

have any effect or be any less attractive as food, refuge, cover and nesting sites as non GE varieties of 

potatoes.

APHIS considered the possibility that Simplot InnateTM potato could serve as a host plant for a 

threatened or endangered species. A review of the species list reveals that there are no members of the 

genus Solanum that serve as a host plant for any threatened or endangered species (USDA-APHIS, 

2014a; 2014b). Considering the lack of expected exposure, and the expectation that exposure would not

produce responses any different than potato varieties currently in production, cultivation of Simplot 

InnateTM potatoes and their progeny are expected to have no effect on threatened or endangered 

animals.

Summary

After reviewing the possible effects of allowing the environmental release of Simplot InnateTM potato,

APHIS has not identified any stressor that could affect the reproduction, numbers, or distribution of a 

listed TES or species proposed for listing. APHIS also considered the potential effect of a determination 

of nonregulated status of Simplot InnateTM potato on designated critical habitat and habitat proposed 

for designation, and could identify no differences from effects that would occur from the production of 

other potato varieties. Potato is not considered a competitive plant species and has been selected for 

domestication and cultivation under conditions not normally found in natural settings (Holm et al., 1979; 

Muenscher, 1980; Love, 1994; OECD, 1997). There is no ability of Simplot InnateTM potato to naturally 

hybridize with any wild Solanum species, including listed species. Simplot InnateTM potato will not serve 

as a host species for any listed species or species proposed for listing. Consumption of Simplot InnateTM 

potato by any listed species or species proposed for listing will not result in a toxic or allergic reaction. 

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Based on these factors, APHIS has concluded that a determination of nonregulated status of Simplot 

InnateTM potato, and the corresponding environmental release of these potato events will have no effect 

on listed species or species proposed for listing, and would not affect designated habitat or habitat 

proposed for designation. Because of this no-effect determination, consultation under Section 7(a)(2) of 

the Act or the concurrences of the USFWS or NMFS is not required.

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7 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES RELATING TO

ENVIRONMENTAL IMPACTS

7.1 Executive Orders with Domestic Implications

The following executive orders require consideration of the potential impacts of the Federal action to 

various segments of the population.

• Executive Order (EO) 12898 (US-NARA, 2010), "Federal Actions to Address Environmental 

Justice in Minority Populations and Low-Income Populations," requires Federal agencies to 

conduct their programs, policies, and activities that substantially affect human health or the 

environment in a manner so as not to exclude persons and populations from participation in 

or benefiting from such programs. It also enforces existing statutes to prevent minority and 

low-income communities from being subjected to disproportionately high and adverse

human health or environmental effects. 

• EO 13045, “Protection of Children from Environmental Health Risks and Safety Risks,”

acknowledges that children may suffer disproportionately from environmental health and 

safety risks because of their developmental stage, greater metabolic activity levels, and 

behavior patterns, as compared to adults. The EO (to the extent permitted by law and 

consistent with the agency’s mission) requires each Federal agency to identify, assess, and 

address environmental health risks and safety risks that may disproportionately affect 

children.

Neither the No Action nor the Preferred Alternative is expected to have a disproportionate adverse 

effect on minorities, low-income populations, or children because Simplot InnateTM potato events 

are agronomically, phenotypically, and biochemically similar to conventional potatoes except for the 

low acrylamide potential and reduced black spot bruise traits. To establish that the new cultivars 

are nutritionally equivalent to their parent cultivars, Simplot InnateTM potato and the control Ranger 

Russet potato were subjected to nutritional and proximate analysis, and measured for free amino 

acids, total amino acids, glycoalkaloids, sugars, and acrylamide levels. This means they are not likely 

to have adverse effects on individuals within those populations when they are consumed. At 

present, studies suggest that potatoes represent over 30 % of vegetable consumption in U.S. 

children in and out of school (Olsho and Fernandes, 2013) and that urban/minority youths are more 

likely to consume more fried potato products than youths living in a non-urban environment (Davis 

and Carpenter, 2009). Olsho and Fernandes (2013) suggest that the targeting of potato preparation 

methods may represent a more viable method to improve the healthfulness of potato dishes, and as 

such, the introduction and use of Simplot InnateTM potato may improve any disparate adverse effect 

associated with potato consumption in the United States. 

Reduced free asparagine (ASN) and total ASP + ASN, increased free GLN and total GLU + GLN, 

reduced acrylamide, and lowered reducing sugars were observed and expected as a result of gene 

85
silencing. This reduction could benefit consumers by addressing a food safety issue in potato 

industry (NTP, 2011). Other unexpected significant differences were reported, but the values are all 

within the normal ranges for potatoes. J3 tubers contained an average of 0.117 mg/100 g 

pyridoxine (vitamin B6) as compared to the controls, which had 0.124 mg/100g. J55 also had 

decreased pyridoxine. J3 tubers had an average of 134 ppm of free VAL as compared to the 

controls, which had 147 ppm. J55 also experienced decreased VAL; H37 had decreased LYS; F37 had 

increased free ARG; G11 had increased total LYS and PRO; F10 and F37 had increased vitamin C and 

niacin; E12 and E24 had decreased sucrose; and H37 had increased sucrose. These deviations in 

various amino acids and vitamins, while experimentally significant, do not exceed the range of 

variation observed in conventional potato varieties (USDA-APHIS, 2013a). 

Potatoes also were tested for reducing sugars and acrylamide after storage. Many of the events had 

lowered levels of reducing sugars at the time of harvest or one month of storage, but significant 

differences were not routinely observed after 2-5 months compared to conventional potato 

varieties. Storage up to 7 months yielded consistently lower acrylamide levels in most events than 

in the controls, although there were exceptions with the G and H varieties. Overall, the 

modifications from insertion of pSIM1278 resulted in reductions in acrylamide that persisted 

throughout the storage period.

Research confirmed that the overall levels of natural glycoalkaloids, a toxin commonly found in 

solanaceous crops including potato, were not increased in the Simplot InnateTM events. The safety 

limit is 20mg/100g as described by Sinden (1987). There were, however, higher mean levels of 

glycoalkaloids in the G event (20.3 mg/100g) and the comparative untransformed control (19.8 

mg/100g), but this was attributed to additional handling at the storage sites and subsequent 

exposure to light and temperature fluctuations (Simplot, 2013b). As presented in the APHIS PPRA 

(2013a), while some Simplot InnateTM potato events exhibited higher glycoalkaloid content (e.g., G 

event), its respective controls also exhibited higher glycoalkaloid levels and that these observed 

concentrations of glycoalkaloids still remain in the range of typical potato glycoalkaloid levels 

described in the literature. This finding suggests that there are no safety concerns with Simplot 

InnateTM potato due to similarities in composition.

Patatin is a potato storage glycoprotein that makes up approximately 40 percent of the soluble 

protein in tubers. Although patatin was not measured during the studies (Simplot, 2013b), any 

potential exposure to patatin is not expected to be different as a result of a determination of 

nonregulated status for Simplot InnateTM potato. Some allergies have been detected in children as a 

result of patatin; however, these allergies are only in children and are uncommon (De Swert et al., 

2002; 2007). Children who are allergic to potatoes would avoid potatoes under the No Action 

Alternative; therefore, any changes in patatin levels in Simplot InnateTM potato would not impact 

these children, as they are already avoiding potatoes due to the high proportion of patatin already 

occurring in conventional potato varieties (Mignery et al., 1988).

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In summary, the compositional data presented in the Simplot petition (2013a) and analyzed in the 

APHIS PPRA (2013a) indicates that Simplot InnateTM potato does not substantially differ from 

conventional potato varieties with the exception of the introduced traits. As a result, Simplot 

InnateTM potato is not expected to have a disproportionate adverse effect on minorities, low-income 

populations, or children.

Simplot initiated the consultation process with FDA for the commercial distribution of Simplot 

InnateTM potato and submitted a safety and nutritional assessment of food and feed derived from 

Simplot InnateTM potato to the FDA (Simplot, 2013b). FDA is presently evaluating the submission. 

The following executive order addresses Federal responsibilities regarding the introduction and effects 

of invasive species:

EO 1311 (US-NARA, 2010), “Invasive Species,” states that Federal agencies take action 

to prevent the introduction of invasive species, to provide for their control, and to 

minimize the economic, ecological, and human health impacts that invasive species 

cause. 

Based on historical experience with potatoes and data submitted by the applicant and reviewed by 

APHIS, Simplot InnateTM potato is not expected to become weedy or invasive. Potatoes are not listed in 

the United States as a noxious weed species by the Federal government (7 CFR Part 360) (USDA-NRCS, 

2014), nor is it listed as an invasive species by major invasive plant databases. Standard potato-growing 

practices make it highly unlikely that potatoes would persist in a field from one crop cycle to the next. In 

areas where potatoes are grown as a rotation crop, any potatoes left in the field generally are

eliminated by tilling, field preparations with herbicides, and harsh winters. To maximize an economic 

return, potato growers rarely leave the ground fallow. Any potatoes inadvertently growing in a fallow 

field are not protected with insecticides or fungicides; they would be susceptible to the Colorado potato 

beetle and early blight, and likely die.

Potatoes are not known to escape from fields (become feral) or show weediness potential. Potato 

seedlings grown from tubers have difficulty establishing because they are poor competitors against 

grasses, trees, and shrubs. The traits incorporated into Simplot InnateTM potato are not associated with 

weediness and these traits will not help plants thrive outside of cultivation. 

The following executive order requires the protection of migratory bird populations:

EO 13186 (US-NARA, 2010), “Responsibilities of Federal Agencies to Protect Migratory 

Birds,” states that federal agencies taking actions that have, or are likely to have, a 

measurable negative effect on migratory bird populations are directed to develop and 

implement, within two years, a Memorandum of Understanding (MOU) with the Fish 

and Wildlife Service that shall promote the conservation of migratory bird populations. 

87
APHIS has in place a signed MOU with the FWS (USDA-APHIS and USFWS, 2012). In accordance with this 

MOU, APHIS has considered the potential impacts of InnateTM potato on migratory birds.

Based on historical experience with potatoes and data submitted by the applicant and reviewed by 

APHIS, Simplot InnateTM potato is expected to have the same interactions with migratory birds as 

conventional potatoes. The applicant provided data to demonstrate the compositional equivalency of 

InnateTM potato and other potato varieties currently grown. The modifications did not alter the quality of 

potato as food other than lower levels of acrylamide after cooking, and lower black spot bruise. There 

would be no effect from consumption of InnateTM potato plant parts because there is nothing different 

between the plant parts of these varieties and plant parts of other potato varieties already in 

production. Migratory birds are not attracted to potato fields for potatoes; however, waterfowl forage 

extensively in agricultural fields in the fall and winter and are at risk for exposure to pesticides. In 

addition, raptors are at risk of exposure to pesticides if they consume dead or dying waterfowl from the 

fields. With regard to pesticide use, the ten Simplot InnateTM potato events are similar to their 

conventional cultivated potato counterparts, and therefore would not require additional use of pesticide 

applications. No “take” of a migratory bird is expected as a result of growing InnateTM potato, and APHIS 

could not determine any mechanism by which take would occur, or would occur any differently than 

production of any other potato variety.

7.2 International Implications

EO 12114 (US-NARA, 2010), “Environmental Effects Abroad of Major Federal Actions” requires 

agencies to consider the potential environmental effects outside the U.S., its territories, and possessions 

for proposed federal actions. APHIS does not expect a significant environmental impact outside the 

United States in the event of a determination of nonregulated status of Simplot InnateTM potato because 

existing national and international regulatory authorities and phytosanitary regimes will apply. 

Any international trade of Simplot InnateTM potato subsequent to a determination of nonregulated 

status of the product would be fully subject to national phytosanitary requirements and be in 

accordance with phytosanitary standards developed under the International Plant Protection 

Convention (IPPC, 2010). In April 2004, a standard for PRA of living modified organisms (LMOs) was 

adopted at a meeting of the governing body of the IPPC as a supplement to an existing standard, 

International Standard for Phytosanitary Measure No. 11 (ISPM-11, Pest Risk Analysis for Quarantine 

Pests). This standard acknowledges that all LMOs will not present a pest risk and that a determination 

needs to be made early in the PRA for importation as to whether the LMO poses a potential pest risk 

resulting from the genetic modification. APHIS pest risk assessment procedures for genetically 

engineered organisms are consistent with the guidance developed under the IPPC. 

Issues that may relate to commercialization and transboundary movement of particular agricultural 

commodities produced through biotechnology are addressed through treaties, in international forums,

and through national regulations. These sources include the North American Plant Protection 

Organization (NAPPO), the Organization for Economic Cooperation and Development (OECD), and the 

88
North American Biotechnology Initiative (NABI), among others. For example, the Cartagena Protocol on 

Biosafety is a treaty under the United Nations Convention on Biological Diversity (CBD) that established 

a framework for the safe transboundary movement, with respect to the environment and biodiversity, 

of LMOs, which include those modified through biotechnology. Exporters need to comply with the 

regulations that importing countries who are Parties to the Protocol have promulgated. The first 

intentional transboundary movement of LMOs intended for environmental release (field trials or 

commercial planting) will require consent from the importing country under an advanced informed 

agreement (AIA) provision, which includes a requirement for a risk assessment consistent with Annex III 

of the Protocol and the required documentation.

LMOs imported for food, feed, or processing (FFP) are exempt from the AIA procedure, and are covered 

under Article 11 and Annex II of the Protocol. Under Article 11, Parties must post decisions to the 

Biosafety Clearinghouse database on domestic use of LMOs for FFP that may be subject to 

transboundary movement. To facilitate compliance with obligations to this protocol, the Federal 

government developed a website that provides the status of all regulatory reviews completed for 

different uses of bioengineered products (NBII, 2010). The applicable data used in analyses of Simplot 

InnateTM potato events will be available to the Biosafety Clearinghouse. 

7.3 Compliance with Clean Water Act and Clean Air Act

This EA evaluated the potential changes in potato production associated with a determination of 

nonregulated status of Simplot InnateTM potato (Section 4.2) and determined that the cultivation of 

Simplot InnateTM potato would not lead to the increased production or acreage of potato in U.S. 

agriculture. The ten Simplot InnateTM potato events do not possess traits that would allow them to be 

grown in areas other than those where their conventional counterparts are grown. The low acrylamide 

potential and reduced black spot bruise trait conferred by the genetic modification to Simplot InnateTM 

potatoes would not result in any changes in water usage for cultivation. As discussed in Section 4.3, 

there are no expected negative impacts to water resources or air quality associated with Simplot 

InnateTM potato production. Based on these analyses, APHIS concludes that a determination of 

nonregulated status of Simplot InnateTM potatoes would comply with the Clean Water Act and the Clean 

Air Act.

7.4 Impacts on Unique Characteristics of Geographic Areas

This EA determined the cultivation of Simplot InnateTM potato would not lead to the increased 

production or acreage of potato in U.S. agriculture because the ten Simplot InnateTM potato events do 

not possess traits that would allow them to be grown in areas other than those where their 

conventional counterparts are grown. The low acrylamide potential and reduced black spot bruise trait 

conferred by the genetic modification to Simplot InnateTM potatoes would not result in any changes in 

water usage for cultivation. As discussed in Section 4.3, there are no expected negative impacts to 

water resources or air quality associated with Simplot InnateTM potato production. Based on these 

89
analyses, APHIS concludes that a determination of nonregulated status of Simplot InnateTM potatoes 

would comply with the Clean Water Act and the Clean Air Act.

7.5 Impacts on Unique Characteristics of Geographic Areas

This EA determined the cultivation of Simplot InnateTM potato would not lead to the increased 

production or acreage of potato in U.S. agriculture because the ten Simplot InnateTM potato events do 

not possess traits that would allow them to be grown in areas other than those where their 

conventional counterparts are grown. A determination of nonregulated status for Simplot InnateTM 

potatoes is not likely to lead to impacts to unique characteristics of geographic areas because these 

varieties lack characteristics of weediness and lack pollen that is wind-borne over long distances. In 

particular, their water-use characteristics do not suggest an ability to invade riparian areas or wetlands.

7.6 National Historic Preservation Act (NHPA) of 1966 as Amended 

The NHPA of 1966 and its implementing regulations (36 CFR 800) require Federal agencies to: 1) 

determine whether activities they propose constitute "undertakings" that have the potential to cause 

effects on historic properties and 2) if so, to evaluate the effects of such undertakings on such historic 

resources and consult with the Advisory Council on Historic Preservation (i.e., State Historic Preservation 

Office, Tribal Historic Preservation Officers), as appropriate. 

APHIS’ proposed action, a determination of nonregulated status of Simplot InnateTM potato is not 

expected to adversely impact cultural resources on tribal properties. Any farming activity that may be 

taken by farmers on tribal lands would only be conducted at the tribe’s request; thus, the tribes would 

have control over any potential conflict with cultural resources on tribal properties. APHIS sent letters 

to Tribal entities when this petition was declared complete and made available to the public. There 

were no comments received from any tribal entities. 

APHIS’ Preferred Alternative would have no impact on districts, sites, highways, structures, or objects 

listed in or eligible for listing in the National Register of Historic Places, nor would it likely cause any loss 

or destruction of significant scientific, cultural, or historical resources. This action is limited to a 

determination of non-regulated status of Simplot InnateTM potato.

APHIS’ proposed action is not an undertaking that may directly or indirectly cause alteration in the 

character or use of historic properties protected under the NHPA. In general, common agricultural 

activities conducted under this action do not have the potential to introduce visual, atmospheric, or 

noise elements to areas in which they are used that could result in effects on the character or use of 

historic properties. For example, there is potential for increased noise on the use and enjoyment of a 

historic property during the operation of tractors and other mechanical equipment close to such sites. A 

built-in mitigating factor for this issue is that virtually all of the methods involved would only have 

temporary effects on the audible nature of a site and can be ended at any time to restore the audible 

qualities of such sites to their original condition with no further adverse effects. Additionally, these 

90
cultivation practices are already being conducted throughout the potato production regions. The 

cultivation of Simplot InnateTM potato is not expected to change any of these agronomic practices that 

would result in an adverse impact under the NHPA.

91
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